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 Type  malfunction  

Manufacturer Narrative

Our product evaluation lab received one bipolar pacing catheter, model pe074f5 with attached monoject 1.3 cc limited volume syringe.The reported pacing issue was confirmed.Continuity testing confirmed a full open condition in the distal circuit.The proximal circuit was found to be continuous.A cut down of the catheter body was performed, just proximal side of the proximal electrode to expose the pacing lead wires.Continuity testing confirmed, a full open condition around catheter tip.It was also confirmed, that the distal circuit was continuous from just proximal side of the proximal electrode to distal connector pin.The balloon inflated clear and concentric with 1.3 cc air and remained inflated for five minutes without leakage.There was no visible damage or defect observed from the balloon, windings returned syringe or the catheter body.An engineering evaluation was initiated to assess for any manufacturing-related processes, which could be correlated to the complaint.A supplemental will be sent with the results, as well as the device history record review results when completed.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported, that from the beginning of use after the catheter insertion.This catheter was unable to pace.The issue was resolved by replacing the catheter.Information regarding what kind of surgery or examination the catheter was used for or whether the patient had a cardiac conduction defect was unavailable.The patient demographic information was requested, but unavailable.There were no patient complications reported.

Manufacturer Narrative

An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.A product risk assessment was previously generated for the full open and intermittent condition at tip for bipolar pacing catheters for products nonconformance with moderate, major, or critical severity.Additionally, a capa was generated to address the pacing difficulty failure effect for bipolar products with full open, intermittent, and short conditions on bipolar models.The root cause was related to manufacturing.A device history record review was completed and documented that device met all specifications upon distribution.Corrections to the h6 codes investigation findings and investigation conclusions were made.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; one 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 ; 9492503939
• MDR Report Key: 17502109
• MDR Text Key: 321050789
• Report Number: 2015691-2023-15159
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

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 Operator: Health Professional
• Device Model Number: PE074F5
• Device Lot Number: 64568143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/10/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2022
• 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