BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1222887 · Received November 6, 2008

    Report

    Report Number
    3005099803-2008-06098
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 5, 2008
    Report Date
    October 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THE RESOLUTION CLIP DEVICE WAS USED DURING THE ESOPHAGOGASTRODUODENOSCOPY (EGD) OF THE STOMACH. WHEN DEPLOYING THE CLIP INSIDE THE PATIENT, THE CLIP WOULD NOT CLOSE PROPERLY. ONE SIDE APPEARED TO HAVE BEND. THE PHYSICIAN ATTEMPTED TO DEPLOY ANOTHER CLIP. THE SAME EVENT OCCURRED FOR THE ANOTHER CLIP ALSO. THE CLIPS CAME OFF INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE THIRD CLIP. IT IS REPORTED THAT THE PATIENT HAS MULTI COMORBITIES. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE. REFER TO ASSOCIATED MANUFACTURER REPORT # 3005099803-2008-06097 FOR A DESCRIPTION OF THE OTHER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522610 0ML8062506

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR