MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER (FOR FEMORAL INSERTION); CATHETER, FLOW DIRECTED

Model Number D97130F5

Device Problems Material Separation (1562); Component Missing (2306); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.

Event Description

It was reported that during use of a swan-ganz pacing catheter, the balloon detached during removal from the patient.Per the advanced practice nurse (apn) who performed the removal, the patient did not require pacing throughout the night; therefore, after consulting with the physician in the morning, she was approved to pull the catheter.As she was removing the catheter, she met with resistance so applied negative pressure with the syringe and pulled harder.Upon inspecting the catheter, the balloon ("white coating") was noted to be missing and the ¿wires were split¿ so she "aspirated 10cc from the sheath" and then pulled it to allow for bleeding in anticipation of the missing piece coming out; however, no bleeding occurred.She contacted the treating physician and a stat echocardiogram was ordered, which only showed artifact.A chest ct was also performed, and was also negative.The apn noted that other nurses had examined the sheath upon removal and felt that they could see something inside of it, though it was not confirmed at the time and the catheter was packaged up to be sent to the hospital¿s quality department for evaluation.The patient did not suffer any apparent consequences or injury and was subsequently discharged without incident the following day.The patient demographics are unknown.The lot number is unknown.The apn stated that upon discussing the incident with another physician to solicit his advice for future catheter removals, they retrieved the suspect catheter and dissected the sheath, where they found the missing balloon.She then left the area and was not present to find out if the catheter was re-packaged for return after that, but believes it remains available for return from the hospital's quality department, who was present during the examination she and the physician performed on the suspect product.Additionally, the apn reports that a radiology tech called her to ask if she ¿loosens the hub from the sheath prior to catheter removal¿ which she states she does not.Per the apn, she is not involved in the insertion of these catheters and was not provided any official training by her facility on the removal of them, so is unsure if she is using the proper steps for removal.An in-service and/or visit from the ew field specialist has been requested and is being coordinated.

Manufacturer Narrative

Our product evaluation laboratory received one model d97130f5 catheter with a non-edwards introducer.As received, the valve of the non-edwards introducer was in the closed position and the introducer was cut at the proximal end of the sheath.The body tube under the balloon latex was completely broken at the proximal electrode lead wire port.The edges at the break locations appeared to match.There was a complete bond separation between the proximal electrode and the body tube, and adhesive could be seen on the body tube.Both the distal electrode and proximal electrode leadwires were broken.The customer report of catheter damage was confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Swan-ganz pacing thermodilution (td) catheters serve as diagnostic and therapeutic tools in the management of critically ill patients.There are multiple failure modes that may require the exchange of a pacing catheter.Since proper functioning of the pacing catheter depends on the electrical continuity of its electrodes and internal wires, care should be exercised when handling the catheter.Stretching, kinking, or forceful wiping of the catheter may result in damage.After stable pacing has been confirmed, the proximal end of the catheter should be secured to the insertion site to prevent undue movement that could result in tip dislodgment and loss of capture, or catheter migration.Care should be taken not to kink the catheter body when securing it.In this complaint, it could not be determined if procedural factors or device handling may have contributed to the reported event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Manufacturer Narrative

Medwatch report # (b)(4) was received, which contained additional information.The patient was a 78 year-old male with aortic stenosis who had undergone transcatheter aortic valve replacement (tavr).During the procedure, he developed a complete heart block and a temporary transvenous pacer (ttvp) was inserted via a right femoral approach.The next day, the apn removed the ttvp, as previously reported.The cardiologist that inspected the catheter found the tip inside of the white luer lock cap compartment, which the apn stated she did not loosen prior to removing the suspect catheter but also stated that she does not routinely do so.

Manufacturer Narrative

Reference capa-20-00141.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER (FOR FEMORAL INSERTION)
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8211048
• MDR Text Key: 132243676
• Report Number: 2015691-2019-00024
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K822723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D97130F5
• Device Catalogue Number: D97130F5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 85