MAUDE Adverse Event Report: EDWARDS LIFESCIENCES 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 Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for evaluation but the investigation has not been completed.A supplemental report will be forthcoming when the investigation is completed, as well as the device history record review results.H3 other text : device not returned.

Event Description

It was reported that during use, it was unable to pace.Pacing was attempted after catheter insertion, but it did not work.The customer readjusted the catheter position, but the problem persisted.The issue was resolved by replacing the catheter.Information including the kind of surgery or examination the catheter was used for and if the patient had cardiac conduction defect was unknown.The patient demographic information was requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

Our product evaluation lab received one bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe at gate valve.The reported issue of unable to pace was confirmed.The balloon failed to maintain its inflation due to leakage from partial bond detachment between proximal electrode and catheter body.Continuity testing confirmed a full open condition of the proximal circuit.The distal circuit was found to be continuous.A cut down of the catheter body and the balloon found the proximal leadwire to be broken near the proximal electrode port under the balloon.It was confirmed that the proximal circuit was continuous from broken lead wire to proximal connector pin.No visible damage or defect was observed from the balloon, windings and returned catheter.A device history record review was completed and documented that device met all specifications upon distribution.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 to cover 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 and is in the control phase.The root cause was related to manufacturing.Updates to the h6 codes are as follows type of investigation was changed to historical data analysis and communication interviews.Investigation findings were changed to manufacturing process problem identified investigation conclusions was changed to cause traced to manufacturing.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC 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
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18685092
• MDR Text Key: 336097258
• Report Number: 2015691-2024-00941
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• 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: 64983625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2023
• 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