BEUDAMED
    FDA Adverse Event Summary report: N

    ROTABLATOR GUIDE WIRE

    MDR report key: 1200445 · Received September 9, 2008

    Report

    Report Number
    2134265-2008-02974
    Date Received
    September 9, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 19, 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 WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI), A GUIDEWIRE FRACTURE OCCURRED. THE DE NOVO 90% STENOSED LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEGREE OF CALCIFICATION WAS UNKNOWN, AND THE TORTUOSITY OF THE VESSEL WAS UNKNOWN. THE 325 CM ROTAWIRE FLOPPY WAS BROKEN 120CM TO THE DISTAL TIP DURING THE ROTATING TEST. THIS OCCURRED SUCCESSFULLY WITH A NEW UNSPECIFIED GUIDEWIRE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR GUIDE WIRE MCX CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC FLOPPY ROTAWIRE 11734530

    Patients

    Seq Age Sex Outcome Treatment
    1 LAUNCHER GUIDECATHETER| RUNTHROUGH GUIDEWIRE| RYUJIN BALLOON CATHETER