inforMED
InjuryHCG

TARGET XL 360 SOFT 3MM X 9CM

Received May 28, 2026 · Event occurred May 8, 2026

Report 3008881809-2026-00340 · MDR key 25323308

Device

Generic name

Device, Neurovascular Embolization

Catalog number

M0036123090

Lot number

24146602R

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Unknown

  • Ruptured Aneurysm

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DETACHMENT OF THE SUBJECT COIL WAS ATTEMPTED MORE THAN 10 TIMES USING THE POWER SUPPLY, BUT WAS UNSUCCESSFUL. BECAUSE DETACHMENT COULD NOT BE ACHIEVED, THE SUBJECT COIL RETRIEVAL WAS ATTEMPTED, DURING WHICH AN ANEURYSM RUPTURE OCCURRED. THE SUBJECT COIL STRETCHED DURING RETRIEVAL AND WAS SUBSEQUENTLY REMOVED USING A SNARE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE PATIENT IS STABLE.