BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR GUIDE WIRE

    MDR report key: 1221234 · Received November 5, 2008

    Report

    Report Number
    2134265-2008-04233
    Event Type
    Injury
    Date Received
    November 5, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MGF: 2134265-2008-04234. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMENAL CORONARY INTERVENTION (PTCA) PROCEDURE, WITHDRAWAL DIFFICULTIES WERE ENCOUNTERED AND A GUIDE WIRE FRACTURE OCCURRED. THE ARTERY AND LESION LOCATION AND CHARACTERISTICS ARE UNKNOWN. THE ROTABLATOR (RTW) FLOPPY GUIDEWIRE WAS USED WITH A ROTALINK BURR AND ADVANCED TO THE LESION. AFTER THE FIRST ABLATION WITH THE BURR, IT BECAME STUCK IN THE ARTERY. FORCE WAS APPLIED TO THE BURR AND ATTEMPTS TO WITHDRAW WERE UNSUCCESSFUL. THE PHYSICIAN THEN ACTIVATED THE BURR AT 140,000 RPM'S AND THE BURR WAS SUCCESSFULLY REMOVED, HOWEVER, THE DISTAL TIP OF THE GUIDE WIRE BROKE. THE GUIDE WIRE FRAGMENT REMAINS IN THE PATIENT. IT WAS REPORTED THAT NO ACTION WAS TAKEN TO RESOLVE THE EVENT AT THAT TIME, NOR IS IT KNOWN IF THE EVENT HAS BEEN RESOLVED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. POST PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED AS "STABLE". NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR GUIDE WIRE MCX CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC FLOPPY RTW 11517838

    Patients

    Seq Age Sex Outcome Treatment
    1 Other