BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH CARD PUD W/BA

    MDR report key: 720079 · Received August 5, 2005

    Report

    Report Number
    2648988-2005-00026
    Event Type
    Malfunction
    Date Received
    August 5, 2005
    Report Date
    August 5, 2005
    Manufacturer
    INTEGRA NEUROSCIENCES INC.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGERY, THE DOCTOR ATTEMPTED TO INSERT THE ARTERIAL CATHETER INTO AN INRODUCER, BUT IT WAS IMPOSSIBLE. THE INTRODUCER THE CUSTOMER USED WAS PEEL-AWAY INTRODUCER MANUFACTURED BY COOK, C-PLO-7.0-35-X-1, FRENCH SIZE WAS 7.0. IT SEEMED THAT ONE OF THE BLACK MARKERS ON THE CATHETER TOUCHED THE INSIDE OF THE INTRODUCER BECAUSE THE HEIGHT OF THE MARKER WAS HIGHER THAN USUAL AND IT OBSTRUCTED THE CATHETER TO PASS THE INTRODUCER SMOOTHLY. THOUGH THE DOCTOR TRIED TO INSERT THE CATHETER INTO ANOTHER PEEL-AWAY INTRODUCER (SAME SIZE), BUT HE FAILED AGAIN. THEN THE CUSTOMER USED AN EXTRA CATHETER, WHICH HAS THE SAME LOT #1043408. IT PASSED THROUGH THE INTORDUCER AND WAS IMPLANTED IN THE PT WITHOUT ANY TROUBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH CARD PUD W/BA CSF CATHETERS JXG INTEGRA NEUROSCIENCES INC. * 1043408

    Patients

    Seq Age Sex Outcome Treatment
    1