BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJECTION GOLD PROBE BIOPLAR CATHETER

    MDR report key: 1060233 · Received June 12, 2008

    Report

    Report Number
    3005099803-2008-00686
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVALUATION WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED. REFERENCE MDR NUMBER: 3005099803-2008-00687.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC WAS INFORMED THAT DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, AN INJECTION GOLD PROBE BIPOLAR CATHETER WAS USED TO TREAT GI BLEED IN PT. THE PT HAD INJECTION AND CAUTERIZATION WITH THE GOLD PROBE. WHEN THE PHYSICIAN WAS ATTACHING THE END OF THE GOLD PROBE TO DO THE LAVAGE, HE COULD NOT GET A TIGHT FIT (A GOOD SEAL) TO THE CONNECTOR AND BECAME BENT. THE PHYSICIAN USED ANOTHER GOLD PROBE AND THE SAME THING HAPPENED. THE PT WAS BLEEDING SEVERELY AND THE CASE WAS ABORTED. THE PT IS BELIEVED TO BE ADMITTED IN ICU FOR MONITORING. THE PHYSICIAN GAVE THE PT BLOOD PRODUCTS AND ANESTHESIA TO MAKE PT COMFORTABLE. THE PHYSICIAN PERFORMED THE PROCEDURE AGAIN ON THE FOLLOWING DAY WITH MONITORED ANESTHESIA CARE. THE PHYSICIAN USED ANOTHER GOLD PROBE AND A THERAPEUTIC SCOPE AND WAS SUCCESSFUL IN CONTROLLING THE BLEEDING. THE PT HAD A BLOOD CLOT. THE PT WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION GOLD PROBE BIOPLAR CATHETER KNS BOSTON SCIENTIFIC CORPORATION M00560150 0011408300

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R