MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN GANZ BIPOLAR PACING CATHETER AND KIT FOR FEMORAL INSERTION; ELECTRODE, PACEMAKER, TEMPORARY

Model Number PEK075F5

Device Problem Pacing Problem (1439)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.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 a part of the monthly review.

Event Description

It was reported a swan ganz was unable to pace from the beginning of use after the catheter insertion for tavi procedure.The issue was resolved by replacing the catheter.It is unknown if the patient had cardiac conduction defect.Patient demographic information was requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

The reported issue of pacing issue was confirmed.Continuity testing confirmed a full open condition in the distal circuit.The proximal circuit was found to be continuous.A cut down of the catheter body was performed just proximal of the proximal electrode to expose the pacing lead wires.The distal lead wire was found to be broken, detached around the solder joint.It was found that the distal circuit was continuous from broken lead wire to distal connector pin.The balloon inflated clear and concentric with 1.3 cc air and remained inflated for 5 min.Without leakage.No visible damage or defect was observed from the balloon, windings, catheter body, and returned syringe.A device history record review was completed and documented that device met all specifications upon distribution.Engineering evaluation was completed.A capa was initiated for this issue and a product risk assessment was needed.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 a part of the monthly review.

• Brand Name: SWAN GANZ BIPOLAR PACING CATHETER AND KIT FOR FEMORAL INSERTION
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 15349699
• MDR Text Key: 301014847
• Report Number: 2015691-2022-07673
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K813521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2022

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 Expiration Date: 04/14/2023
• Device Model Number: PEK075F5
• Device Lot Number: 63707857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1