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

Model Number PE074F5

Device Problem Pacing Problem (1439)

Patient Problem Cardiac Arrest (1762)

Event Date 06/13/2022

Event Type  Injury  

Manufacturer Narrative

The reported event of pacing issue was confirmed.Continuity testing found that a short condition occurred in the catheter body.Cut down was performed and revealed that the insulation of proximal lead wire was missing from under the proximal electrode to 4.8 cm from catheter tip.Insulation of distal lead wire was missing from under the proximal electrode to 2.1 cm from proximal tip.This condition allowed the leadwires to make contact and caused the short condition.After separating both wires, no short condition was observed, and continuous condition was confirmed between distal electrode and distal connector pin and between proximal electrode and proximal connector pin.The balloon inflated clear and concentric and remained inflated for 5min.Without leakage.No visible damage was observed from catheter body, balloon, windings, 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.

Event Description

It was reported that a swan ganz was unable to pace from the beginning of use after the catheter insertion, which caused the patient temporarily going into a cardiac arrest.The catheter was used for the patient with complete atrioventricular block during an external pacing procedure.The external pacemaker was replaced but the problem was not solved.Then, the issue was resolved by replacing the catheter.After the catheter replacement, the heart rate was restored.The causality between the device and the event was reported as related.Patient demographic information was requested but unavailable.The patient outcome is well.There was no allegation of subsequent complication.

Manufacturer Narrative

Additional information was obtained from the sales rep.It was reported chest compression might have been performed while the patient was in cardiac arrest, but the detail is unknown.The patient was bradycardic before inserting the pacing catheter.The catheter was used for a scheduled and non urgent procedure.The medical record was unable to be obtained.Correction was made in the d1 section.The product name as cleared was previously used instead of device name.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.An engineering evaluation was completed and concluded that a product risk assessment was needed.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
• MDR Report Key: 14889874
• MDR Text Key: 295226357
• Report Number: 2015691-2022-06559
• 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
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/24/2023
• Device Model Number: PE074F5
• Device Lot Number: 64069136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other; Life Threatening