BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION II CLIP

    MDR report key: 2091718 · Received May 17, 2011

    Report

    Report Number
    3005099803-2011-01699
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K102764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IS OVER 18 YEARS OLD. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION II CLIP DEVICE WAS USED TO TREAT A BLEED IN THE FUNDUS PORTION OF THE STOMACH DURING A HEMOSTASIS PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WOULD NOT RELEASE FROM THE DELIVERY CATHETER. THE SCOPE WAS IN A STRAIGHT POSITION AND THE HANDLE OF THE DEVICE HAD TO BE TORQUED IN ORDER TO RELEASE THE CLIP FROM THE CATHETER. THE CLIP REMAINED ATTACHED TO THE MUCOSA AND NO ADDITIONAL CLIPS WERE REQUIRED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO BE FINE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION II CLIP HEMORRHOID LIGATOR MND BOSTON SCIENTIFIC - MARLBOROUGH M00522511 1ML1012602

    Patients

    Seq Age Sex Outcome Treatment
    1