MalfunctionOFL
ARROW PSI SET: 8.5 FR
Received Apr 24, 2026 · Event occurred Mar 26, 2026
Report 3006425876-2026-00451 · MDR key 24976701
Device
Generic name
Introducer, Catheter
Manufacturer
Arrow International LlcCatalog number
SI-09875-E
Lot number
71F25H1053
Product problems
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT: AT INSERTION OF THE SHEATH, THE CONNECTION BETWEEN THE GUARD AND THE SHEATH BODY GOT DETACHED AND THE SHEATH BODY DETACHED FROM THE GUARD. CHECKING IT, THE CONNECTING PART WAS LOOSENED, SO A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OCCURRED."