BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1973464 · Received January 21, 2011

    Report

    Report Number
    1973464
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A DIAGNOSTIC CARDIAC CATHETERIZATION AND A ROTATIONAL ATHERECTOMY AND ADJUNCTIVE PTCA OF THE LEFT ANTERIOR DESCENDING ARTERY WITH SUBSEQUENT PLACEMENT OF XIENCE DRUG-ELUTING STENT. DURING THE PROCEDURE, THE DISTAL TIP OF THE ROTATIONAL ATHERECTOMY WIRE BROKE IN THE APICAL PORTION OF THE LEFT ANTERIOR DESCENDING ARTERY. NO CLINICAL CONSEQUENCE TO PT. THIS WAS REPORTED TO THE COMPANY BY THE OPERATING PHYSICIAN AS EQUIPMENT FAILURE; THERE WAS NO RESISTANCE FELT ON THE WIRE WHEN THE PHYSICIAN WAS PULLING IT BACK; THERE WAS NO USER ERROR. THE COMPANY TO REPLACE EQUIPMENT/EVALUATE N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC FLOPPY ROTAWIRE MCX BOSTON SCIENTIFIC 22824-002 13669929

    Patients

    Seq Age Sex Outcome Treatment
    1 Other