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 06/20/2023

Event Type  malfunction  

Event Description

It was reported that a swan ganz catheter was unable to pace from the beginning of use after the catheter insertion.The issue was resolved by replacing the catheter.Information such as the background of malfunction occurrence, what kind of surgery or examination the catheter was used for and if the patient had cardiac conduction defect is unknown.Patient demographic information was requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

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

The reported event of pacing issue was confirmed.Continuity test found that a full open condition of the proximal circuit in y adapter.The distal circuit was found to be continuous.No open or short condition was observed in the lead wires between just distal side of y adapter and the electrodes.Short condition was not detected in the circuit proximal of y adapter.No visible damage or abnormality was observed from catheter body, balloon, windings, and returned syringe.The balloon inflated clear and concentric and remained inflated for 5min without leakage.Further evaluation regarding related quality issues is under investigation.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 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.

Manufacturer Narrative

An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.A product risk assessment was previously generated to cover full open condition at y adapter failure for bipolar products.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 SVC INSERTION
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 17259732
• MDR Text Key: 318769614
• Report Number: 2015691-2023-14349
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PE074F5
• Device Lot Number: 64819733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 07/31/2023; 08/17/2023; 09/07/2023
• Supplement Dates FDA Received: 08/15/2023; 08/31/2023; 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2023
• 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