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

Model Number PE075F5

Device Problem Device Damaged Prior to Use (2284)

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

Event Type  malfunction  

Manufacturer Narrative

The product lab received one bipolar pacing catheter with attached monoject 1.3 cc volume limited syringe at gate valve.The reported issue of balloon inflation difficulty was confirmed.A visual examination found that the catheter tip was completely broken off at the inflation port, and the balloon was ruptured around the circumference at the position near the catheter tip breakage.The cross surfaces of broken catheter tip appeared uneven and rough.The edges of balloon latex did not appear to match up.The edges of broken catheter tip sections also did not appear to match up.Continuity testing was performed on the distal and proximal circuits and there were no open, intermittent, or short conditions observed.No other visible damage was observed from balloon windings, catheter body and returned syringe.A device history record review was completed and documented that the 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.

Event Description

It was reported that before use, the balloon failed to maintain its inflation.There were no patient complications reported.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION
• 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: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 17966007
• MDR Text Key: 326054777
• Report Number: 2015691-2023-16912
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• 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: 64772048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2020
• 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