BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE BIPOLAR CATHETER

    MDR report key: 1040833 · Received May 9, 2008

    Report

    Report Number
    3005099803-2008-00447
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED; THEREFORE, A DEVICE EVALUATION WAS NOT PERFORMED. THE CAUSE OF THE TIP DETACHMENT IS UNDETERMINED. A REVIEW OF THE COMPLAINT DATABASE REVEALED NO ADDITIONAL COMPLAINTS RECORDED FOR THIS LOT.

    Description of Event or Problem · 1

    AN INJECTION GOLD PROBE BIPOLAR CATHETER WAS INTENDED TO BE USED FOR HEMOSTASIS (PATIENT AGE, GENDER, AND WEIGHT UNKNOWN) IN 2008. ACCORDING TO THE COMPLAINANT, "UPON OPENING THE PACK, IT WAS SEEN THAT THE GOLD TIP WAS MISSING. IT WAS DETACHED FROM THE CATHETER AND WAS LYING IN THE CATHETER SHEATH." THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION GOLD PROBE BIPOLAR CATHETER KNS BOSTON SCIENTIFIC CORPORATION M00560150 9550723

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK