inforMED
MalfunctionMCW

TURBO ELITE OTW

Received Nov 9, 2012 · Event occurred Nov 1, 2012

Report 2903337 · MDR key 2903337

Device

Generic name

Catheter

Model number

410-152

Catalog number

*

Lot number

F12J12E

Product problems

  • Material Frayed

Patient

86 YR

  • Pain
  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

TIP OF LASER CATHETER "FRAYED/MELTED" OFF INTO PATIENT IN THE ANTERIOR TIBIAL ARTERY OF THE RIGHT LEG. PATIENT REMAINED STABLE THROUGHOUT PROCEDURE. PATIENT C/O PAIN IN RIGHT FOOT, MEDICATED WITH FENTANYL AND VERSED WITH NO GOOD EFFECT. MULTIPLE UNSUCCESSFUL ATTEMPTS MADE TO RETRIEVE OBJECT. DOCTOR WELL AWARE OF SITUATION AND MANAGER OF CATHETERIZATION LAB MADE AWARE.======================MANUFACTURER RESPONSE FOR TURBO ELITE LASER ABLATION CATHETER, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================NOTIFIED BY THE PHYSICIAN.