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

Model Number D97130F5

Device Problem Pacing Problem (1439)

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

Event Type  malfunction  

Event Description

It was reported that a swan ganz was unable to pace from the beginning of the procedure during use.The device was used in transcatheter aortic valve implantation, but it was unknown if it was used for purpose of rapid pacing.The issue was resolved by replacing the catheter.The device was discarded at the hospital due to infection.Patient demographic information was requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

The device was not returned for evaluation.Device was discarded due to exposure to infection.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.A device history record review was completed and documented that device met all specifications upon distribution.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 FOR FEMORAL INSERTION
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 17991182
• MDR Text Key: 326366510
• Report Number: 2015691-2023-17018
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: D97130F5
• Device Lot Number: 64752341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• 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