MalfunctionDRE
PRELUDE ACT¿
Received Jul 10, 2026 · Event occurred May 22, 2026
Report 25778672 · MDR key 25778672
Device
Generic name
Dilator, Vessel, For Percutaneous Catheterization
Manufacturer
Merit Medical Systems, Inc.Model number
FCatalog number
PSI-5F-11ACT
Lot number
PSI-5F-11ACT
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
RECEIVED MERIT MEDICAL PRELUDE ACT SHEATH INTRODUCER FROM IR [INTERVENTIONAL RADIOLOGY]; INNER SHEATH DOES NOT FIT INTO THE CATHETER. IDENTIFIED PRIOR TO USE. NO PATIENT HARM.