MAUDE Adverse Event Report: EDWARDS LIFESCIENCE 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 Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.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.

Event Description

It was reported that a swan ganz was unable to pace from the beginning of use after the catheter was inserted and connected to an external pacemaker.The catheter was intended to be used for tavi procedure.The issue was resolved by replacing the catheter and the procedure was performed successfully.It is unknown if the patient had cardiac conduction detect.Date of event is also unknown.Patient demographic information was requested but unavailable.The device was discarded at the hospital.There were no patient complications reported.

Manufacturer Narrative

Engineering evaluation was completed and concluded that a product risk assessment escalation was met earlier.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 FOR SVC INSERTION
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCE; 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: 16375978
• MDR Text Key: 309563801
• Report Number: 2015691-2023-10804
• 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: 03/21/2023

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: 64496181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/14/2023
• Supplement Dates Manufacturer Received: 03/21/2023
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• 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