MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN GANZ BIPOLAR PACING CATHETER FOR INSERTION VIA SUPERIOR VENA CAVA; CATHETER, FLOW DIRECTED

Model Number D97120F5

Device Problem Capturing Problem (2891)

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

Event Date 09/02/2023

Event Type  malfunction  

Event Description

It was reported that the temporary pacemaker could not capture during a procedure.A 7fr introducer was used.Device was exchanged to resolve the issue.There were no patient injuries.

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product investigation.A supplemental report will be forthcoming with the evaluation when completed.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.

Manufacturer Narrative

A product evaluation was completed.The reported event of pacing issue was confirmed.Continuity testing confirmed a short condition between the electrodes.Cut down on the adaptor found the insulation of the proximal electrode lead wire was damaged.Engineering evaluation was completed.The condition of short due to leadwire insulation damage on the pacing catheter was confirmed.A manufacturing root cause was not able to be determined.The ifu precautions avoid forceful wiping or stretching of the catheter during testing and cleaning as not to break the electrode wire circuitry.Additionally, since proper functioning of the pacing catheter depends on the electrical continuity of its electrode and internal wires, care should be exercised when handling the catheter.Corrections to the h6 codes type of investigations, investigation findings, and investigation conclusions were made.Lot number was previously reported to be 65022591, but the correct lot number is 65067756 per follow up with customer.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 INSERTION VIA SUPERIOR VENA CAVA
• Type of Device: CATHETER, FLOW DIRECTED
• 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: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 17999624
• MDR Text Key: 326820506
• Report Number: 2015691-2023-17041
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103150421
• UDI-Public: (01)00690103150421(17)250509(11)230510(10)65022591
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K822723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: D97120F5
• Device Lot Number: 65067756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2023
• 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