MECHANICAL SIZER SET
Received Jan 13, 2026 · Event occurred Dec 19, 2025
Report 2135147-2026-00270 · MDR key 24054867
Device
Generic name
Sizer, Heart-valve, Prosthesis
Manufacturer
Abbott MedicalModel number
100077364Catalog number
100077364
Lot number
7065792
Product problems
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN EVENT OF DAMAGED MECHANICAL SIZERS WAS REPORTED. IT WAS REPORTED THAT DURING PROCEDURE, IT WAS NOTED THAT THE SIZER GOT BROKEN. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. AS THE EVENT IS NOT REPORTABLE, A LETTER IS NOT REQUESTED AND THERE IS NO INDICATION OF A PRODUCT ISSUE NO DEVICE HISTORY RECORD OR LOT SPECIFIC SIMILAR COMPLAINT REVIEW IS REQUIRED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem
N/A
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 AN UNKNOWN DATE, A MECHANICAL SIZER SET WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT THE SIZER GOT BROKEN.
Additional Manufacturer Narrative
AN EVENT OF DAMAGED MECHANICAL SIZERS WAS REPORTED. IT WAS REPORTED THAT DURING PROCEDURE, IT WAS NOTED THAT THE SIZER GOT BROKEN. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. AS THE EVENT IS NOT REPORTABLE, A LETTER IS NOT REQUESTED AND THERE IS NO INDICATION OF A PRODUCT ISSUE NO DEVICE HISTORY RECORD OR LOT SPECIFIC SIMILAR COMPLAINT REVIEW IS REQUIRED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.