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 Date 04/17/2023

Event Type  malfunction  

Manufacturer Narrative

The device is anticipated to be returned for evaluation but has not yet been received.A supplemental will be sent with the evaluation results, as well as the device history record review results when completed.

Event Description

It was reported that using this swan-ganz bipolar pacing catheter (model pe074f5 lot 64609277), it was unable to pace from the beginning of use after the catheter insertion.The issue was resolved by replacing the catheter.Information such as what kind of surgery or examination the catheter was used for or if the patient had cardiac conduction defect is 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, model pe074f5.The reported pacing issue was confirmed.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 was performed just proximal of the proximal electrode to expose the pacing leadwires.It was observed that the proximal leadwire was broken at 4.3 cm proximal from catheter tip.It was also confirmed that the proximal circuit was continuous from broken lead wire to proximal connector pin.The balloon inflated clear and concentric with 1.3 cc air and remained inflated for 5 minutes without leakage.There was no visible damage or defect was observed from the balloon, windings, and catheter body.A device history record review was completed and documented that the 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.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.

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 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 was changed to manufacturing process problem identified.Investigation conclusions was changed to cause traced to manufacturing.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; one edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 16900055
• MDR Text Key: 314898490
• Report Number: 2015691-2023-12895
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2023

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?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PE074F5
• Device Lot Number: 64609277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2022
• 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