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 03/11/2024

Event Type  malfunction  

Event Description

It was reported that a pe074f5 pacing catheter was unable to pace during use.Pacing was attempted after inserting the catheter into the patient, but it did not work.The catheter was exchanged and the problem was solved.The catheter was discarded at the hospital.There were no patient complications reported.The device was not returned for evaluation therefore, the customer report of unable to pace could not be confirmed.Without return of the unit it is not possible to determine a product non-conformance or device failure associated to manufacturing or design.It is not known if some procedural factors may have contributed to the event.As part of the catheter manufacturing process, 100% of the units go through an electrical continuity inspection, and continuity test performed as per procedure.A device history record review was completed and documented that 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 a part of the monthly review.

• 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 92614
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18995387
• MDR Text Key: 338891920
• Report Number: 2015691-2024-02368
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00690103008746
• UDI-Public: (01)00690103008746(17)250711(11)230712(10)65128044
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: 65128044
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2023
• 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