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 Type  malfunction  

Event Description

It was reported that it was unable to pace during use.Pacing was attempted after catheter 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 with the evaluation and device history results when received.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 on model pe074f5 pacing catheter.The customer report of pacing issue was unable to be confirmed.No visible damage or abnormality was observed from catheter body, balloon, windings and returned syringe.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.An engineering evaluation was performed to assess for any manufacturing related processes which could be correlated to the complaint.No defect was found; therefore a product non-conformance or device failure could not be confirmed and there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect.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.Corrections to the h6 codes type of investigations, investigation findings, and investigation conclusions were made.

• 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; edwards lifescience irvine; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 18601543
• MDR Text Key: 335083003
• Report Number: 2015691-2024-00650
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00690103008746
• UDI-Public: (01)00690103008746(17)250704(11)230705(10)65114736
• 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: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• 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: 65114736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2024
• 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