BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK PLUS

    MDR report key: 1203640 · Received October 16, 2008

    Report

    Report Number
    2134265-2008-03042
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Report Date
    September 16, 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

    .

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2008-03015. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE VESSEL AND LESION CHARACTERISTICS ARE UNK. DURING PLATFORMING OF THE 1.5 MM ROTALINK BURR, OUTSIDE OF THE PT, THE FLOPPY RTW GUIDE WIRE FRACTURED. THE ROTALINK AND ROTAWIRE WERE EXCHANGED FOR ANOTHER OF THE SAME AND THE PROCEDURE WAS COMPLETED. THE EVENT OCCURRED DURING PREP, THUS NO PT CONTACT, NO PT INJURY OR COMPLICATIONS WERE REPORTED. THE PT'S CONDITION WAS REPORTED AS "NO PROBLEM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTALINK PLUS MCX CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC NA 11606417

    Patients

    Seq Age Sex Outcome Treatment
    1