MECHANICAL SIZER SET
Received Jun 8, 2026 · Event occurred Mar 2, 2026
Report 2135147-2026-03871 · MDR key 25435918
Device
Generic name
Sizer, Heart-valve, Prosthesis
Manufacturer
Abbott MedicalModel number
905Catalog number
905
Lot number
11065317
Product problems
- Fracture
Patient
75 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT IS UNKNOWN IF THE DEVICE IS RETURNING FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.
Description of Event or Problem
IT WAS REPORTED THAT ON (B)(6) 2026, A MECHANICAL VALVE SIZER WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT THE PLASTIC FRACTURE AT THE HANDLE OF THE VALVE SIZER OCCURRED IN THE HOSPITAL. THE DISTRIBUTOR HAS CONFIRMED WITH THE HOSPITAL THAT THE HOSPITAL ADOPTS ONE OF THE DISINFECTION METHODS SPECIFIED IN THE CHINESE USER MANUAL OF THE VALVE SIZER. THE HOSPITAL INSPECTS THE VALVE SIZER FOR CRACKS AND DAMAGE BEFORE AND AFTER EACH DISINFECTION. SUBSEQUENTLY, THE SURGEON REPLACED THE VALVE SIZER AND VALVES WITH PRODUCTS FROM OTHER MANUFACTURERS TO COMPLETE THE OPERATION. THE PATIENT HAS RECOVERED AND BEEN DISCHARGED