PACEL BIPOLAR PACING CATHETER
Received May 21, 2026 · Event occurred Apr 23, 2026
Report 3004742232-2026-00117 · MDR key 25246935
Device
Generic name
Electrode, Pacemaker, Temporary
Manufacturer
Abbott Vascular Inc.Model number
401771Catalog number
401771
Product problems
- Difficult to Insert
- Unintended System Motion
- Material Too Rigid or Stiff
- Use of Device Problem
Patient
NA · Unknown
- Pericardial Effusion
Narrative
Additional Manufacturer Narrative
MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.
Description of Event or Problem
IT WAS REPORTED A PACEL CATHETER WAS BEING USED. DURING INSERTION, IT WAS VERY DIFFICULT TO INSERT AND SUDDENLY SLIPPED INTO THE RIGHT ATRIUM. FURTHERMORE, THE MATERIAL WAS DESCRIBED AS VERY STIFF, RIGID, AND DIFFICULT TO HANDLE. SUBSEQUENTLY, THE PATIENT WAS FOUND TO HAVE A PERICARDIAL EFFUSION, WHICH WAS ATTRIBUTED TO THIS INCIDENT. THE PATIENT WAS IN STABLE CONDITION AFTER PERICARDIOCENTESIS WAS PERFORMED.