MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

Model Number PE074F5

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Separation Problem (4043)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 07/18/2018

Event Type  malfunction  

Manufacturer Narrative

One bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe was returned for evaluation.A non-edwards introducer was also attached to the catheter body between 68.5 cm and 89.7 cm proximal from the catheter tip.Blood was visible on the catheter body.The catheter body was looped and tied by suture between 38 and 62.5 cm proximal from the catheter tip.Visual examination found that the catheter tip was completely broken off and the proximal and the distal lead wires were also completely broken off at the proximal electrode and the distal electrode, respectively.Residual adhesive was observed remaining on the catheter tube.Cross surface of the broken proximal lead wire appeared tapered.Insulation appeared to remain on the distal end of the distal lead wire.Cross surfaces of broken catheter tip appeared uneven and rough.Continuity testing confirmed no open, intermittent, or short condition from the distal and proximal circuits between the broken sections and related electrode connector pins, respectively.No visible damage to the balloon, windings, or returned syringe was observed.Balloon inflation testing could not be performed due to catheter tip breakage.Visual examinations were performed under microscope at 20x magnification and with the unaided eyes.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Customer report of ¿the electrode part got detached from the catheter¿ was confirmed during the evaluation.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.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.

Event Description

It was reported that the electrode of the swan ganz pacing catheter detached under the patient¿s skin during catheter removal.The catheter had been placed for approximately one week.The clinician stated that they felt slight resistance upon removal of the catheter.The electrode portion detached from the catheter when the catheter was pulled.Although the detached tip remained in the patient, it was removed using the end of the proximal electrode end that was positioned outside of the patient.After tip removal, no missing catheter remained in the patient¿s body.The pacing catheter was used for a patient with hypertrophic cardiomyopathy during pacemaker implantation surgery.There were no patient complications reported.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION
• Type of Device: PACING CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 7773599
• MDR Text Key: 117016536
• Report Number: 2015691-2018-03316
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K813521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PE074F5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR