BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE WIRES

    MDR report key: 1231071 · Received October 30, 2008

    Report

    Report Number
    2134265-2008-04160
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    September 30, 2008
    Report Date
    September 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQO
    PMA / PMN Number
    K923480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE COATING OF THE GUIDE WIRE WAS "STRIPPED OFF". THE NON-CALCIFIED 80% STENOTIC LESION WAS LOCATED IN THE PROXIMAL SEGMENT OF THE TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE CHOICE PT GUIDE WIRE WAS ADVANCED TO THE LESION AND IT WAS REPORTED THAT THE COATING OF THE GUIDE WIRE WAS VISUALLY SEEN TO BE "STRIPPED OFF" AT THE PROXIMAL SITE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE PATIENT'S CONDITION WAS REPORTED AS "GOOD". ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE WIRES DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC CHOICE PT 11668832

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR