inforMED
InjuryHCG

TARGET 360 NANO 3MM X 4CM

Received Jun 30, 2026 · Event occurred Jun 9, 2026

Report 3008881809-2026-00412 · MDR key 25669783

Device

Generic name

Device, Neurovascular Embolization

Catalog number

M0035443040

Lot number

25816291

Product problems

  • Fracture
  • Expulsion

Patient

57 YR · Female

  • Foreign Body In Patient
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO DETACH THE SUBJECT COIL, BUT THE SUBJECT COIL FAILED TO DETACH. FORCEFUL TRACTION APPLIED TO SUBJECT COIL DELIVERY WIRE, RESULTED IN BREAKAGE AT THE DISTAL SEGMENT OF THE DELIVERY WIRE. THE DETACHED DISTAL SEGMENT COULD NOT BE RETRIEVED. FOLLOW-UP ANGIOGRAPHY REVEALED SUBJECT COIL PROTRUSION, AND A RESCUE STENT WAS PLACED TO MANAGE THIS COMPLICATION. THE PROCEDURE WAS THEN COMPLETED. THERE WAS A SURGICAL DELAY OF UNKNOWN MINUTES DUE TO THE REPORTED EVENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.