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

Model Number PE074F5

Device Problem Pacing Problem (1439)

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

Event Date 04/11/2022

Event Type  malfunction  

Event Description

It was reported that pacing difficulty was observed and it was unable to pace properly from the beginning after the catheter insertion although it was able to sense on the first day of use.The issue was resolved by replacing the catheter.Information such as what kind of surgery and examination the catheter was used for or if the patient had cardiac conduction defect is unknown.Patient demographic information was requested but unavailable.There were no patient complications reported.Additional information was reported from the sales rep.Correct information is that sensing issue was observed and sensing was intermittent after the catheter insertion.It is unknown if pacing was performed.The sales rep received the report from the customer regarding sensing issue only.Further information could not be obtained.

Manufacturer Narrative

The reported event of pacing issue was confirmed.Continuity testing found that the distal lead wire had an intermittent condition around the electrode, when flexing the tip area of the catheter.Proximal circuit was continuous without any intermittent or open condition.No short condition was observed between the proximal and distal lead wires.A cut down was performed to isolate the intermittent condition and the intermittent condition was found to be at distal lead wire tip.The balloon inflated clear and concentric and remained inflated for 5 min.Without leakage.No visible damage was observed from windings, balloon, catheter body, and returned syringe.Further evaluation regarding supplier 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

Engineering evaluation was completed and concluded that a product risk assessment was needed.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.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER
• 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: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 14226577
• MDR Text Key: 290797504
• Report Number: 2015691-2022-05438
• 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: 06/24/2022

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 Expiration Date: 12/16/2023
• Device Model Number: PE074F5
• Device Lot Number: 64113325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2022
• Initial Date FDA Received: 04/27/2022
• Supplement Dates Manufacturer Received: 06/23/2022
• Supplement Dates FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2021
• 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