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

Model Number PE074F5

Device Problems Pacing Problem (1439); No Pacing (3268)

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

Event Date 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is in progress.A supplemental report will be sent with the investigation results.A device history record review was completed and documented that device met all specifications upon distribution.

Event Description

It was reported that the swan ganz catheter was unable to pace in the catheter laboratory from the beginning of use.The customer increased electric potential after catheter insertion, however it was unable to pace.The catheter was exchanged and the problem was solved.It is unknown if the patient had cardiac conduction defect.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe was returned for evaluation.As received, catheter tip was found to be bent.Continuity testing confirmed a full open condition in the proximal and the distal circuits.A cut down of the catheter body was performed just proximal of the proximal electrode to expose the pacing lead wires.The proximal lead wire was found to be broken at the 0.7 cm area from the tip and insulation was not present at the broken section.The distal lead wire was found to be broken around the solder joint.It was found that both the proximal and distal circuits were continuous from the broken section to the connector pin.The balloon inflated clear and concentric with 1.3 cc air and remained inflated for 5 minutes without leakage.No visible damage or defect was observed from the balloon, windings, or returned syringe.Balloon inflation test was performed using returned syringe with 1.3 cc air by holding the balloon under water.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.Customer report of pacing issue was confirmed.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.

Manufacturer Narrative

Corrected data: f10, h6.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: 8997444
• MDR Text Key: 196578434
• Report Number: 2015691-2019-03399
• 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,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2020
• Device Model Number: PE074F5
• Device Lot Number: 61495712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/11/2019
• Supplement Dates Manufacturer Received: 09/11/2019; 07/23/2020
• Supplement Dates FDA Received: 10/02/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1