MalfunctionLDF

PACEL BIPOLAR PACING CATHETER

Received Apr 6, 2026 · Event occurred Mar 13, 2026

Report 3004742232-2026-00084 · MDR key 24791845

Device

Generic name

Electrode, Pacemaker, Temporary

Manufacturer

Abbott Vascular Inc.

Model number

401763

Catalog number

401763

Product problems

Material Rupture

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

Description of Event or Problem

IT WAS REPORTED A PACEL BALLOON RUPTURED DURING THE PROCEDURE. THERE WAS NO RESISTANCE FELT DURING THE PROCEDURE. A NEW PACEL OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.