MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN GANZ BIPOLAR PACING CATHETER WITH ATRIAL PORT; SWAN GANZ PACING CATHETER

Model Number D97130F5

Device Problem Pacing Problem (1439)

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

Event Date 02/13/2024

Event Type  malfunction  

Event Description

It was reported in medwatch (b)(4) that there was a failure with the swan ganz bipolar pacing catheter, during use.The customer states the catheter would not pace during a transcatheter aortic valve replacement.There was no patient harm or injury.

Manufacturer Narrative

The swan ganz bipolar pacing catheter was returned for evaluation.The evaluation results confirmed the reported pacing issue.Continuity testing was performed and a full open condition of the distal circuit was found.The proximal circuit was continuous.An x-ray showed the distal lead wire was detached from the distal electrode.The proximal lead wire near the lumen port had cut into the catheter body.The balloon inflated clear and concentric and it remained inflated for five minutes without leakage.The device history record review is pending, the results will be submitted in a supplemental report.An engineering task has been assigned for further investigation.

Manufacturer Narrative

The engineering evaluation was completed.The pacing difficulty during use issue was confirmed through the product evaluation.Root cause could not be confirmed.As part manufacturing process, 100 percent of the units go through an electrical continuity inspection process.The ifu contains instructions on how to avoid damaging the catheter.Avoid forceful wiping or stretching of the catheter during testing and cleaning as not to break the electrode wire circuitry.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.A product risk assessment was generated for the intermittent condition at tip-distal electrode pacing catheter to cover full open and intermittent condition at tip for bipolar pacing catheters complaints incidence will continue to be monitored.Product evaluation confirmed a cut in the catheter body.In addition, 100 percent of the units go through a final inspection to the appearance of the unit.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing design defect.The device history record review was completed and all manufacturing inspections passed with no non-conformances.".

• Brand Name: SWAN GANZ BIPOLAR PACING CATHETER WITH ATRIAL PORT
• Type of Device: SWAN GANZ PACING CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk km 1.4; anasco, puerto rico 00610 ; * 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES; state rd indus pk km 1.4; anasco, puerto rico 00610 ; * 00610
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18946507
• MDR Text Key: 339010330
• Report Number: 2015691-2024-02158
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103150438
• UDI-Public: (01)00690103150438(17)251004(11)231005(10)65312606
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D97130F5
• Device Lot Number: 65312606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2023
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 146 KG