BIPOLAR PACING 5F FD RH ACC O
Received Oct 9, 2025 · Event occurred Sep 2, 2025
Report 2182269-2025-00118 · MDR key 23262979
Device
Generic name
Electrode, Pacemaker, Temporary
Manufacturer
Abbott MedicalModel number
401624Catalog number
401624
Lot number
10780822
Product problems
- Fracture
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UDI INFORMATION (D4) AND 510K (G3) ARE NOT PROVIDED WITHIN THIS REPORT AS THIS PRODUCT (MODEL 401624) IS AN OUS CONFIGURATION NOT AVAILABLE IN THE US AND IS THEREFORE NOT REFERENCED IN THE GUDID DATABASE.
Description of Event or Problem
DURING A PROCEDURE, THE BALLOON OF THE PACEL CATHETER WAS MISSHAPEN, AND AFTER INSERTION INTO THE PATIENT, IT EXPANDED UNEVENLY. ON REMOVAL, THE BALLOON WAS FOUND TO BE DAMAGED. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.