BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRA BACK-UP 3.5

    MDR report key: 599185 · Received April 27, 2005

    Report

    Report Number
    9616099-2005-00942
    Event Type
    Malfunction
    Date Received
    April 27, 2005
    Date of Event
    March 11, 2005
    Report Date
    April 26, 2005
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DYB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN USED 8FR 3.5 XB (EXTRA BACKUP) GUIDE CATHETER, A BMW STEERABLE GUIDE WIRE (SGW), A S'PORT SGW, A 3X23 OVER THE WIRE (OTW) CYPHER AND A 2.5 X 23 RAPID EXCHANGE (RX) CYPHER FOR LESIONS IN THE MID LAD AND DIAGONAL ARTERIES. DUE TO ADVANCEMENT DIFFICULTIES CAUSED BY THE DEVICE RESISTANCE, THE PHYSICIAN ENDED UP REMOVING ALL THE DEVICES AND REPLACING THEM TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. THE XB GUIDE CATHETER WAS USED TO BEGIN A "STEEP ANGLE" TAKE-OFF FOR THE DIAGONAL ARTERY, WHICH HAD SOME CALICIFICATION. BOTH LESIONS WERE PREDILATED WITH A MAVERICK BALLOON. THE BMW SGW WAS USED FOR THE DIAGONAL AND A S'PORT SGW WAS USED FOR THE LAD. THE 2.5 X 23 CYPHER WAS POSITIONED IN THE OSTIUM OF THE DIAGONAL AND THE 3 X 23 CU[JER WAS POSITIONED IN THE LAD. WHEN THE PHYSICIAN TRIED TO ADVANCE THE BMW SGW, IT WOULD NOT ADVANCE BECAUSE IT WAS STUCK ON THE CYPHER POSITIONED AT THE DIAGONAL OSTIUM, WHICH DID ADVANCE EITHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRA BACK-UP 3.5 CARDIOLOGY GUIDING CATHETER DYB CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR A 3X23MM CYPHER, A 2.5 X 23 MM CYPHER, A BMW SGW,| A S'PORT SG