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 the catheter was unable to pace during use.The problem was solved by replacing the catheter.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 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 min.Without leakage.However, the seal inside the gate valve was found to be deformed.No resistance was felt when opening/ closing the gate valve.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.Based on the available information there is no evidence that supports or confirms the failure mode of pacing issue is associated to a manufacturing/design defect.The complaint for pacing difficulty was unable to be confirmed through product evaluation code since the affected unit was returned for evaluation and no defect was found regarding this reported code.Nevertheless, product evaluation confirmed the product failure code of hubs - deformed - gate valve, which is associated to a manufacturing defect.The complaint does not meet pra escalation triggers.A corrective action is not required at this time.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: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18754572
• MDR Text Key: 336089950
• Report Number: 2015691-2024-01204
• 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: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• 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: 65025027
• 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: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2023
• 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