MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN-GANZ BIPOLAR PACING CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number PE074F5

Device Problem No Pacing (3268)

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

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

The device is anticipated to be returned for evaluation but has not yet been received.A supplemental report will be forthcoming when the investigation is completed, as well as the device history record review results.H3 other text : device not returned.

Event Description

It was reported that during use with this pacing catheter, it was unable to pace.The pacing was attempted after catheter insertion, but it did not work.The issue was resolved by replacing the catheter.Information including the kind of surgery or examination the catheter was used for and if the patient had a cardiac conduction defect was unknown.The patient demographic information was requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

Our product evaluation lab received one bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe.The reported pacing issue was confirmed.Continuity testing found that a short condition occurred between the proximal and distal circuits in the y-adaptor.There were no open or short conditions observed in the leadwires between the distal side of y-adaptor and the electrodes.There was no other visible damage observed from catheter body, balloon, and windings.The balloon inflated clear and concentric and remained inflated for five minutes without leakage.An engineering evaluation was performed to assess for any manufacturing related processes which could be correlated to the complaint.The complaint failure is associated to a manufacturing/design defect.As part of the manufacturing process 100% of the units go through an electrical continuity inspection process.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 part of this monthly review.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18839759
• MDR Text Key: 337070416
• Report Number: 2015691-2024-01595
• 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,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PE074F5
• Device Lot Number: 65100753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2023
• 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