inforMED
MalfunctionMOF

SYNCHRO SELECT-14 SUPPORT ST 215CM

Received Jun 2, 2026 · Event occurred May 21, 2026

Report 3012931345-2026-00096 · MDR key 25363822

Device

Generic name

Guide, Wire, Catheter, Neurovasculature

Catalog number

SSUP215STR

Lot number

0001276211

Product problems

  • Fracture

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THIS IS 2ND OF 2 MDRS.

Description of Event or Problem

IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE WAS BROKE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.