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

Model Number PE074F5

Device Problem Pacing Problem (1439)

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

It was reported that during use of this catheter, it was unable to pace.The catheter was used for rapid pacing in a tavi procedure.The issue was resolved by replacing the catheter.Whether 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

The device is anticipated to be returned for evaluation but has not yet been received.A supplemental will be sent with the evaluation results, as well as the device history record review results when completed.

Manufacturer Narrative

One bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe was returned for evaluation.The reported event of a pacing issue was confirmed.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 5 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.Is potentially related to manufacturing defect.The condition short condition in y adapter is potentially related to a manufacturing defect, however, based on the investigation and the information available, a root cause could not be determined.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.Corrected data: updates to the h6 codes are as follows: type of investigation was changed to testing of actual/suspected device, historical data analysis, communication/interviews investigation findings was changed to manufacturing process problem identified investigation conclusions was changed to cause not established.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION
• 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: 18375682
• MDR Text Key: 331375342
• Report Number: 2015691-2023-18629
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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: 65052533
• 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: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2023
• 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