BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER

    MDR report key: 1213109 · Received October 23, 2008

    Report

    Report Number
    3005099803-2008-05466
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED A FRACTURED CERAMIC TIP AT THE CATHETER INSERTION POINT; THE CONDITION OF THE DEVICE PRECLUDED THE ABILITY TO PERFORM AN ELECTRICAL EVALUATION. ALTHOUGH THE CAUSE OF THE FRACTURED TIP IS UNDETERMINED, IT IS LIKELY ATTRIBUTABLE TO PROCEDURAL USE (I.E. OPERATIONAL CONTEXT). THE DEVICE HISTORY RECORD FOR THE PERTINENT LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO ADDITIONAL COMPLAINTS REPORTED FOR THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT AN INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED IN 2008. ACCORDING TO THE COMPLAINANT, THE PROBE DID NOT OUTPUT HEAT DURING THE PROCEDURE. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER KNS BOSTON SCIENTIFIC CORPORATION M00560150 11164160

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK