BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER

    MDR report key: 1140639 · Received August 28, 2008

    Report

    Report Number
    3005099803-2008-04163
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K970278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED BUT A DEVICE ANALYSIS HAS NOT BEEN COMPLETED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED. THE JULY 2008, 15-MONTH GOLD PROBES HEMOSTASIS CATHETER PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO REPORTED MALFUNCTIONS, WHICH OCCURRED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER DEVICE WAS USED IN 2008 . ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, "THE PROBES WOULD NOT HEAT UP." A SECOND GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER WAS SELECTED TO COMPLETE THE PROCEDURE. REFER TO MFR REPORT #3005099803-2008-04164 FOR DETAILS REGARDING THE SECOND REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER KNS BOSTON SCIENTIFIC CORPORATION M00560220 11713017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK