BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR GUIDE WIRE

    MDR report key: 1172446 · Received September 19, 2008

    Report

    Report Number
    2134265-2008-02743
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WAS COMPLETED. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    SAME EVENT AS MFR REPORT #: 2134265-2008-02742. IT WAS REPORTED THAT IN PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE, A WIRE FRACTURE OCCURRED. THE LESION TO BE TREATED WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. DURING PLATFORMING AT A SPEED OF 180,000 RPMS, THE FLOPPY ROTAWIRE GUIDE WIRE FRACTURED. THE LOCATION OF THE FRACTURE WAS MID-SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICES, AND PATIENT STATUS WAS REPORTED AS 'NO PROBLEM'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR GUIDE WIRE MCX CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC FLOPPY ROTAWIRE 11731033

    Patients

    Seq Age Sex Outcome Treatment
    1