inforMED
InjuryKGZ

ACCUSTICK? II

Received Jul 7, 2026 · Event occurred Jun 16, 2026

Report 2124215-2026-36436 · MDR key 25740463

Device

Generic name

Introducer, Catheter

Model number

M001207040

Catalog number

M001207040

Lot number

0035396663

Product problems

  • Detachment of Device or Device Component

Patient

NA · Unknown

  • Foreign Body In Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE GUIDEWIRE TIP FRACTURED AND DETACHED, REQUIRING INTERVENTION. THE TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED VESSEL. A 0.038" ACCUSTICK II DEVICE WAS SELECTED FOR USE DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY AND DRAINAGE (PTCD) PROCEDURE IN THE BILIARY TRACT. DURING REMOVAL OF THE GUIDEWIRE, RESISTANCE WAS ENCOUNTERED. UPON WITHDRAWAL, THE GUIDEWIRE TIP WAS OBSERVED TO HAVE FRACTURED AND DETACHED WITHIN THE PATIENT'S BODY. AN ATTEMPT WAS MADE TO RETRIEVE THE DETACHED FRAGMENT USING A SNARE; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO THE OPERATING ROOM, WHERE THE DETACHED GUIDEWIRE FRAGMENT WAS SUCCESSFULLY REMOVED VIA SURGICAL INTERVENTION. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.