inforMED
MalfunctionHCG

TARGET TETRA 4.5MM X 10CM

Received May 21, 2026 · Event occurred May 6, 2026

Report 3008881809-2026-00323 · MDR key 25247870

Device

Generic name

Device, Neurovascular Embolization

Catalog number

TG5414510

Lot number

25379776

Product problems

  • Premature Separation

Patient

61 YR · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING A COILING PROCEDURE, THE COIL WAS PARTIALLY DEPLOYED BY THE PHYSICIAN, THE PHYSICIAN WANTED TO REDEPLOY THE SUBJECT COIL AS SOME LOOPS WERE COMING OUTSIDE. IN THE PROCESS THE SUBJECT COIL GOT STUCK IN THE MICROCATHETER AND THERE WAS RESISTANCE IN THE MICROCATHETER. THE SUBJECT COIL GOT STUCK IN THE MICROCATHETER AND IT GOT SELF-DETACHED WITHIN THE MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.