inforMED
InjuryDQX

SYNCHRO2-14 STANDARD STRAIGHT 200CM

Received Jul 17, 2026 · Event occurred Jun 10, 2026

Report 3012931345-2026-00114 · MDR key 25854901

Device

Generic name

Wire, Guide, Catheter

Catalog number

M00326410

Lot number

0001144825

Product problems

  • Fracture

Patient

NA · Female

  • Paralysis
  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING A MCA STENOSIS TREATMENT, WHEN THE PHYSICIAN DEPLOYED A NON-STRYKER STENT AT THE TREATMENT SITE, IT WAS NOT APPOSING TO THE VESSEL WALLS. THE PHYSICIAN USED THE SUBJECT GUIDEWIRE TO TRY TO OPEN THE STENT. DURING THE MANIPULATION, THE GUIDEWIRE TIP FRACTURED AT THE PROXIMAL END OF THE STENT. THE TIP OF THE GUIDEWIRE REMAINED LODGED INSIDE THE STENT AND WAS NOT RETRIEVED. THERE WAS A SURGICAL DELAY OF 1 HOUR. POSTOPERATIVELY, THE PATIENT DEVELOPED CONTRALATERAL LIMB HEMIPLEGIA. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.