BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBO ELITE OTW

    MDR report key: 2903337 · Received November 9, 2012

    Report

    Report Number
    2903337
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 9, 2012
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBO ELITE OTW CATHETER MCW SPECTRANETICS CORP. 410-152 F12J12E

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR