BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1083221 · Received July 24, 2008

    Report

    Report Number
    3005099803-2008-01261
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE MAY 2008 15-MONTH HEMOSTATIC CLIPPING PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    THIS REPORT IS THE FOURTH OF FOUR RELATED TO THE EVENT. REFER TO MFR REPORTS #3005099803-2008-01262, 3005099803-2008-01263, AND #3005099803-2008-01264 FOR DETAILS RELATED TO THE OTHER THREE EVENTS. ACCORDING TO THE COMPLAINANT, "DURING THE PROCEDURE THREE OF THE CLIPS DEPLOYED SUCCESSFULLY, BUT THE... PHYSICIAN HAD TO JINGLE THE CATHETER TO RELEASE THE CLIPS... ANOTHER CLIP WAS PULLED OFF AND DID NOT DEPLOY CORRECTLY." THE PHYSICIAN COMPLETED THE PROCEDURE 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 AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522610 OML7073108

    Patients

    Seq Age Sex Outcome Treatment
    1