MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER; CATHETER, FLOW DIRECTED

Model Number D97120F5

Device Problem Pacing Problem (1439)

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

Event Date 10/19/2023

Event Type  malfunction  

Manufacturer Narrative

One bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe was returned for evaluation.The reported pacing issue was confirmed.The continuity testing found that a short condition occurred between the proximal and distal circuits in the y adaptor.There was no open or short condition observed in the leadwires between distal side of y adaptor and the electrodes.There was no visible damage observed from catheter body, balloon, and windings.The balloon inflated clear and concentric and remained inflated for five minutes without leakage.A device history record review was completed and documented that device met all specifications upon distribution.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.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 that during use after catheter insertion, it was unable to pace.The issue was resolved by replacing the catheter.The following information was unknown regarding the background of malfunction occurrence, what kind of surgery or examination the catheter was used for, or whether the patient had cardiac conduction defect.The patient demographic information was requested but not available.There were not patient complication reported.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18108048
• MDR Text Key: 328630592
• Report Number: 2015691-2023-17390
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K822723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D97120F5
• Device Lot Number: 64752350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2023
• 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