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 09/01/2023

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.Background of malfunction occurrence, what kind of surgery or examination the catheter was used for or whether the patient had cardiac conduction defect are 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 when received.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

The reported event of pacing issue was confirmed.Continuity test found that a full open condition of the distal circuit in y adapter.The proximal 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.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.Corrections to the h6 codes type of investigations, investigation findings, and investigation conclusions were made.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: 17788441
• MDR Text Key: 323922389
• Report Number: 2015691-2023-16067
• 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
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PE074F5
• Device Lot Number: 64838944
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2023
• 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