BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1253137 · Received December 5, 2008

    Report

    Report Number
    3005099803-2008-07000
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    October 1, 2008
    Report Date
    November 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE SUSPECT DEVICE IS UNKNOWN; THEREFORE, THE MANUFACTURER AND EXPIRATION DATES CANNOT BE DETERMINED. THE SUSPECT DEVICE IS NOT AVAILABLE FOR EVALUATION. A DEVICE EVALUATION WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IN 2008, BOSTON SCIENTIFIC CORPORATION WAS INFORMED THAT A PATIENT WAS ADMITTED TO THE HOSPITAL FOR A GASTROINTESTINAL BLEED. DURING THE ESOPHAGOGASTRODUODENOSCOPY EGD, THE PHYSICIAN ATTEMPTED TO PLACE A RESOLUTION CLIP DEVICE OVER THE VESSEL, HOWEVER, THE PLACEMENT WAS UNSUCCESSFUL AS THE ULCER WAS IN A "CHALLENGING" AREA TO TREAT. DURING ATTEMPTS AT TREATMENT WITH THE CLIP, THE ULCER BEGAN BLEEDING ACTIVELY. THE PHYSICIAN TREATED THE BLEED BY INJECTING EINEPHRINE AROUND THE VISIBLE ULCER SITE AND THEN TREATED THE VISIBLE VESSEL BLEEDING SITE WITH A CAUTERY DEVICE. THERE IS NO EVIDENCE OF FURTHER BLEEDING. PATIENT WAS REPORTED TO BE DOING "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention