MalfunctionDRE
PRELUDE
Received Jun 16, 2026 · Event occurred May 15, 2026
Report 1721504-2026-00239 · MDR key 25524432
Device
Generic name
Dilator, Vessel, For Percutaneous Catheterization
Manufacturer
Merit Medical Systems Inc.Catalog number
PSI-6F-11-025/CN
Lot number
H3418900
Product problems
- Deformation Due to Compressive Stress
- Material Deformation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A CORONARY ANGIOGRAPHY PROCEDURE WHEN REMOVING THE SHEATH, THE SHEATH TUBE WAS ELONGATED AND DEFORMED. THE PROVIDER USED A BALLOON TO EXPAND THE SHEATH BEFORE REMOVING IT. NO PATIENT INJURY.
Additional Manufacturer Narrative
THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. A FOLLOW-UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.