PACEL FLOW DIRECTED PACING CATHETER
Received Oct 27, 2025 · Event occurred Oct 16, 2025
Report 2182269-2025-00137 · MDR key 23391561
Device
Generic name
Electrode, Pacemaker, Temporary
Manufacturer
Abbott MedicalModel number
401764Catalog number
401764
Lot number
10786086
Product problems
- Material Separation
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING A TAVI (AORTIC VALVE STENOSIS) PROCEDURE, IT WAS OBSERVED THAT THE DISTAL PORTION OF THE CATHETER HAD DETACHED WHILE INSIDE THE SHEATH. THE SHEATH WITH FRAGMENT INSIDE WAS REMOVED FROM THE PATIENT. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE FRAGMENT WAS DISCARDED BY THE HOSPITAL.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D9, G3, H2, H3, H6. ONE 5F PACEL (FLOW DIRECT) PACING CATHETER WAS RECEIVED FOR ANALYSIS. THE DISTAL TIP ELECTRODE WAS NOTED TO BE FRACTURED AND DETACHED FROM THE CATHETER SHAFT. THE FRACTURED AND DETACHED TIP ELECTRODE WAS NOT RETURNED WITH THE DEVICE. THE BATCH RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED.