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

Model Number PE075F5

Device Problem Pacing Problem (1439)

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

Event Type  malfunction  

Event Description

It was reported that during use of this swan-ganz bipolar pacing catheter, it was unable to pace.Pacing was attempted after the 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 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 model pe075f5 catheter.The customers report of pacing issue was confirmed.A continuity test found that a full open condition of the proximal circuit in y-adapter.The distal circuit was found to be continuous.There was no open or short condition was observed in the lead wires between just distal side of y-adapter and the electrodes.A short condition was not detected in the circuit proximal of y-adapter.There was 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 five min without leakage.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.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 completed to assess for any manufacturing related processes which could be correlated to the complaint.It could not be confirmed that the failure condition being evaluated is associated to design or the manufacturing process or that there was a product non conformance that potentially contributed 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.

• 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18047451
• MDR Text Key: 327065859
• Report Number: 2015691-2023-17183
• 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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PE075F5
• Device Lot Number: 64780027
• 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: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2023
• 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