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 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use after catheter insertion, it was unable to pace.The issue was resolved by replacing the catheter.The following information was unavailable regarding the background of the malfunction occurrence, what kind of surgery or examination the catheter was used for or whether the patient had cardiac conduction defect.The patient demographic information was requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One bipolar pacing catheter with an attached monoject volume limited 1.3 cc syringe was returned for examination.The reported event of a pacing issue was unable to be confirmed.There was an open condition observed between the proximal connector to the proximal electrode.The short condition was also observed between both distal and proximal connectors.A cut down confirmed both conditions were due to the broken proximal leadwire in the y adapter.There was no visible damage or abnormality observed from the catheter body, balloon, windings, and returned syringe.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.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.Correction: updates to the h6 codes are as follows: type of investigation was changed to testing of actual/suspected device, historical data analysis, communication/interviews, analysis of production records investigation findings was changed to manufacturing process problem identified investigation conclusions was changed to cause traced to manufacturing.

• 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: 18108051
• MDR Text Key: 328481209
• Report Number: 2015691-2023-17391
• 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: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2015
• Device Model Number: PE074F5
• Device Lot Number: 64905320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2023
• 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