Our esteemed colleague Dr. Ajay Kirtane asked our cath lab experts how to address a problem encountered in his laboratory:

Dear Colleagues,
I was called to the lab to provide some advice. A challenging access case required a coronary 0.014-inch wire to deliver a micropuncture sheath into the internal jugular vein (the standard micropuncture wire couldn’t be manipulated into the superior vena cava [SVC]). At some point during the sheath insertion, the distal fragment of the wire broke off (possibly sheared by the needle?). This was not recognized at the time of the procedure, and eventually diagnosed subsequently by CT scan. The wire fragment was removed without a problem in a separate procedure, but for a variety of reasons has triggered a significant quality improvement (QI) review.
My question is, do any of you have a formal policy for either of the following:

1. Surgical-like “counts” for all wires and/or devices introduced into the body in the cath lab?
2. Formal documentation (or policy) of inspection of wires/devices upon removal from the body?
3. Anything else besides an informal best practice standard to inspect all equipment when it is removed?

Mort Kern, Long Beach, California:  Sorry to hear of this occurring, but I know of no formal tracking of equipment count or such for percutaneous coronary intervention (PCI); maybe for electrophysiology (EP) pacer work in the surgical fashion. During difficult manipulations, a wire break is usually suspected when wire is withdrawn against some resistance. Inspection might not reveal the missing part but suspicion should be high. I have at times opened another wire to compare lengths.  Let’s see what our colleagues say.

Mitchell W. Krucoff, Raleigh, North Carolina:  I agree — what I tend to emphasize is the importance of observing under fluoro while removing the wire if there has been any difficulty manipulating any wire, or if there is a feel of resistance where there shouldn’t be, or when angulations seem quite acute. Actually, we do this most with coronary wires, especially when we trap a wire in a side branch with stent in the mother vessel. We watch the entire removal sequence under fluoro. I have a handful of cases where we were able to appreciate that the wire at the distal weld was deforming, and changed our approach to withdrawal, preventing fracture and getting the whole thing (looking pretty mangled, but whole) out of the body.

Allen Jeremias, Stony Brook, New York:  We had a similar situation where the tip of a wire was left in the body after insertion of a central line in the CCU. It was removed later without complications, but we also had an extensive QI and have now instituted a new policy of central line insertion. It basically consists of 2 people (either resident/fellow or fellow/RN) examining the wire after removal and documenting (separately) that it was removed in its entirety. It’s a bit painful but we haven’t had any further incidences since.

Sam Butman, Verde Valley, Arizona:  I would add that for coated coronary and 0.035-inch Glide wires, shearing off non-radio-opaque material is also an important issue. It makes one wonder about what we do not know at times. Ever remove a balloon catheter tip when finishing a case and wonder what could have happened? Try it sometime and marvel that we do not lose those as well.

Michael Ragosta, Charlottesville, Virginia: We have a policy for sharps and for retained products. I have attached it if anyone is interested (see Table 1). Mostly, we made the sharps policy to protect techs and nurses. We had a few cases were a needle was wrapped in gauze and left on the drapes, and the techs or nurses stuck themselves when gathering up the dirty drapes to discard.
For retained products, it’s mostly to account for the rare balloon that breaks, and to account for the possibility of avulsed balloon material and for stents that may have embolized or wires that have broken.

Lloyd W. Klein, Chicago, Illinois:  As the longstanding quality officer both in cardiology and in the department of medicine at several institutions, I must say that one does not need a formal policy that overtly requires inspection of equipment at the end of a procedure. That is expected and is a no-brainer. Loss of pieces of equipment and/or retained material should always be a quality indicator that sets off a timely investigation and then discussed at your M&M and/or quality meetings. We have so many process indicators now that we follow of doubtful validity; this is definitely not one of those! A broken guide wire with loss of the tip requiring a follow-up procedure should be something the cath lab director is all over from the start, including a discussion with the operator and the staff to determine whether there was a technical, mechanical, or product issue; if it turns out to be operator-dependent, everyone should benefit from understanding what the opportunity for improvement is — this is an event of the highest seriousness.

Malcolm Bell, Rochester, Minnesota:  I agree with Lloyd. This discussion should remind us, where applicable, never to manipulate wires through a needle unless they are standard introducer wires. We had a “nice” example of the coating shaved off of a Glide wire in this manner many years ago.

Bonnie Weiner, Worchester, Massachusetts:  To highlight Lloyd’s comment that not all of these [events] need a subsequent procedure — over the years, I suspect that many of us have left small pieces of wires behind in the coronaries with no sequellae. Yes, it is usually a break in technique somewhere, occasionally a product defect, and even less commonly, a patient issue. [One must always ask] where did this piece wind up?  Was it really necessary to remove it? Is the treatment worse than the disease?  It is important to keep that in perspective.

George Vetrovec, Richmond, Virginia: [As noted by Dr. Weiner] Make sure the broken piece needs to be removed. I have seen great harm from trying to remove bits and pieces and no harm from leaving a wire fragment behind. Make sure there is a good reason to remove it besides “it shouldn’t be there”! [These comments emphasize that the risk/benefit of retrieval must be carefully assessed – MK]

Aaron Kaplan, Dartmouth, New Hampshire: I would like to add to this conversation by providing my perspective from being involved in device development and manufacturing. The manufacturer has a real interest (and legal responsibility) in understanding the frequency and specifics of these [device failure] events.  

I would suggest in your formal or informal processes after device failure of this type should be 1) To inform the manufacturer; 2) Provide supporting clinical data; and 3) Provide as much of the material as possible, e.g., the guide wire (both parts), needle use and packaging (UDI, unique device identifier). It would be best for you to generate a “note to file” immediately after identifying an event, providing as much procedural detail as possible. This will supply the manufacturer with the necessary data and material to perform detailed analysis. All device manufacturers are obligated to monitor these events, will have (ISO/GMP) established processes in place, and will generate a formal report that you can request.  

The knowledge gleaned from a good/consistent post market surveillance program is important in identifying a manufacturing issue (unlikely in the example above) or a procedural issue (certain micro needles-wire combinations may be more shear-ogenic than others) and will no doubt inform future design decisions.

Mladen Vidovich, Chicago, Illinois: The VA performs real-time device surveillance. As others have pointed out, device surveillance has inherent challenges. Events are under-reported. Reporting is frequently voluntary and we have a difficulty with the numerator/denominator for these events.

To address some of these issues, the VA has one EMR and one structured cath lab reporting system (CART), i.e., all cath labs report all procedures with the same granular report and they are all stored in one central place. Embedded in CART is a tool that tracks unexpected device complications. These VA cath lab reports are then linked to the FDA, which then generates the FDA MedWatch Form 3500A to be completed and filed. As an example, in 260,258 cath reports from 8/06-2/12, there were 739 level I, 196 level II, and 39 level III events. Of the 39 level III reports, 12 were in the submission phase as a FDA MedWatch report. Although this system is structured and centralized, limitations remain due to manual data entry and limited discrete data.

The steps that are currently being implemented within the VA to overcome these limitations are: 1) RFID real-time locator services for cardiology equipment and 2) central inventory management that would then allow for device recall management and more structured post-market device surveillance.

Reference

Tsai, TT et al. Feasibility of proactive medical device surveillance: the VA Clinical Assessment Reporting and Tracking (CART) program. Med Care. 2013 Mar; 51 (3 Suppl 1): S57-S61. doi: 10.1097/MLR.0b013e31827da819. Available online at https://journals.lww.com/lww-     medicalcare/Abstract/2013/03001/Feasibility_of_Proactive_Medical_Device.12.aspx. Accessed December 24, 2014.

George Vetrovec, Richmond, Virginia: I have to respond to Dr. Kaplan. I suspect most hospital risk departments would recommend retaining any broken materials at the hospital, so that if litigation occurs, an independent agency could review. Every time I have sent something back to a manufacturer, they have reported “user error” as the cause of any breakage.   

Kirk Garratt, New York City, New York: We don’t have equipment accounting, because, unlike surgeons, we don’t let go of stuff put inside the body. It always extends to the outside world, unless we intend to leave it. A sheared wire tip isn’t subtle, especially for coronary wires. As everybody should know, they’re constructed with a wound filament designed to help retrieve a broken distal portion.  Shearing it off at the needle tip requires enough force to be noticed by an experienced operator. To be honest, a full QI review on this is a good idea, not to beat up on the operator, but to understand why it wasn’t noticed.  This might call for additional education for the operator.

The bottom line

The key to managing broken equipment is attention to the feel of the equipment during manipulations and constant awareness of the potential for break or malfunction leading to retained materials. Experience is critical to this awareness, with inspection of all catheters, wires, and leads on removal to ensure the operator of device integrity. Whether the retrieval of a fragment of a broken wire is absolutely required depends on the risk/benefit of the retrieval process minimizing any harm while ensuring best protection for the patient. Proper documentation of the procedure, status of the device, and review of the procedure should be part of every such event. Whether the fractured material should be sent to the manufacturer depends on the local hospital risk assessment team. I hope this conversation will prompt all labs to review their policies and practices for managing fractured and retained equipment.

My great appreciation goes to my colleagues for their contributions, insights, and wisdom, and their willingness to share these with us.

Morton Kern, MD
Clinical Editor; Chief of Medicine,
Long Beach Veterans
Administration Health Care
System, Long Beach, California;
Associate Chief Cardiology,
Professor of Medicine,
University of California Irvine,
Orange, California
mortonkern2007@gmail.com

Also on Cath Lab Digest: https://www.cathlabdigest.com/article/SCAI-Opening-its-Membership-Entire-Cath-Lab-Team