PACEL FLOW DIRECTED PACING CATHETER
Received Aug 26, 2025 · Event occurred Jul 26, 2025
Report 3005334138-2025-00521 · MDR key 22900367
Device
Generic name
Electrode, Pacemaker, Temporary
Manufacturer
Abbott MedicalModel number
401763Catalog number
401763
Lot number
10648653
Product problems
- Material Separation
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem
DURING TAVI PROCEDURE WHEN THE TEMPORARY PACEMAKER WAS IMPLANTED IN THE PATIENT, AND THE BALLOON IN THE PACING LEAD RUPTURED. THE PACEL WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE HARM TO THE PATIENT. THE DEVICE WAS DISCARDED.