BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP

    MDR report key: 1161379 · Received September 12, 2008

    Report

    Report Number
    3005099803-2008-04555
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIFTH OF FIVE DEVICES THAT WERE USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MANUFACTURER REPORTS #3005099803-2008-04556, #3005099803-2008-04557, #3005099803-2008-04558, AND #3005099803-2008-04559 FOR A DESCRIPTION OF THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 14, 2008 THAT A RESOLUTION CLIP WAS USED DURING A ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE IN 2008 FOR TREATMENT OF ACTIVE BLEEDING. ACCORDING TO THE COMPLAINANT, "THE PHYSICIAN BENT THE SHEATH". THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP MND BOSTON SCIENTIFIC CORPORATION M00522612 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK