MAUDE Adverse Event Report: ABBOTT MEDICAL PACEL BIPOLAR; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 401794

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

Event Date 05/02/2023

Event Type  malfunction  

Event Description

The flow-directed pacing catheter would not pace after placement into the patient.The catheter was removed and replaced without incident or harm to the patient.Manufacturer response for flow directed pacing catheter, flow directed pacing catheter (per site reporter), unknown.

• Brand Name: PACEL BIPOLAR
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ABBOTT MEDICAL; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 17434380
• MDR Text Key: 320144318
• Report Number: 17434380
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 401794
• Device Lot Number: 8901676
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1