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

Model Number PE074F5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Cardiac Tamponade (2226)

Event Date 04/14/2023

Event Type  Injury  

Manufacturer Narrative

The device was discarded at the hospital.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.No corrective actions will be taken at this time.The lot number was not provided thus a device history record was not reviewed.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 right ventricular perforation occurred during catheter insertion on the first day of use.Per follow up with sales rep, it was reported that the pacing catheter was used temporarily prior to pacemaker implantation.The catheter insertion and pacemaker implantation were performed on a different date respectively.The date of catheter insertion is unknown.On (b)(6) 2023, the physician noticed that the catheter tip had perforated the right ventricular wall and the patient had been experiencing cardiac tamponade.The issue was noted in the catheter laboratory when the physician examined the heart of the patient under radiographic guidance in order to perform pacemaker implantation.A cardiac surgeon performed a repairing procedure immediately.After the repairing procedure, pacemaker implantation was also performed.The physician did not notice right ventricular perforation and cardiac tamponade until the day of pacemaker implantation since the amount of blood leakage was small.The patient outcome is well.Patient demographic information was requested but unavailable.The severity was determined as non serious by the physician.There was no potential for resulting death or disability due to the event.The causality between the device and the event was reported as low and the physician stated that the event was not due to the catheter malfunction.The device was discarded at the hospital.

Manufacturer Narrative

As reported, the physician noticed that the catheter tip had perforated the right ventricular wall and the patient had been experiencing cardiac tamponade.The issue was noted in the catheter laboratory when the physician examined the heart of the patient under radiographic guidance in order to perform pacemaker implantation.The instructions for use, under complications perforation of the right ventricle states as follows, cases of myocardial perforation associated with the use of temporary transvenous pacing catheters have been reported.Careful repositioning and withdrawal of the catheter under ecg and fluoroscopic control is recommended.In this reported event, a repairing procedure was performed immediately and the patient outcome is well.The physician stated that the event was not probably due to the catheter malfunction.There was no allegation or indication a device malfunction contributed to this adverse event.Investigation results suggest the root cause is related to a procedural error.Complaint histories for all reported events are reviewed through trending on a monthly basis and continue to be monitored for any unfavorable trends and documented as part of this monthly review.No corrective or preventative actions are required at this time.Investigation findings h6 codes were updated to no findings available and usage problem identified.Investigation conclusions h6 codes were changed to adverse event related to procedure, caused traced to non device factors, and cause traced to user.B2 was corrected to include required intervention to prevent permanent impairment damage.

• 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; one edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 16900051
• MDR Text Key: 314885191
• Report Number: 2015691-2023-12894
• 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: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: PE074F5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention