MAUDE Adverse Event Report: EDWARDS LIFESCIENCE IRVINE TRANSLUMINAL BIPOLAR PACING PROBE; ELECTRODE, PACEMAKER, TEMPORARY

Model Number PE074F5

Device Problem Pacing Problem (1439)

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

Event Date 02/29/2024

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.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.

Manufacturer Narrative

Our product evaluation lab received one model pe074f5 bipolar pacing catheter.The customer report of pacing issue was unable to be confirmed.Continuity testing was performed on the distal and proximal circuits and there were no open, intermittent, or short conditions observed.The balloon inflated clear and concentric with 1.3 cc air and the balloon remained inflated for 5 minutes without leakage.No visible damage or abnormality was observed from balloon, windings, catheter body and returned syringe.An engineering evaluation was performed to assess for any manufacturing related processes which could be correlated to the complaint.As part of the catheter manufacturing process, 100% of the units go through an electrical continuity inspection.The complaint for pacing difficulty was unable to be confirmed through product evaluation since the affected unit was returned for evaluation and no defect found was found.Therefore based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect.

• Brand Name: TRANSLUMINAL BIPOLAR PACING PROBE
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCE IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCE IRVINE; 1 edwards way; irvine CA
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18942788
• MDR Text Key: 338201824
• Report Number: 2015691-2024-02144
• 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
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PE074F5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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