BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 2010060 · Received March 8, 2011

    Report

    Report Number
    3005099803-2011-00644
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IS OVER (B)(6). THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT A RESOLUTION HEMOSTASIS CLIPPING DEVICE WAS USED IN THE CECUM DURING A CLIPPING PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE ONTO THE TARGET TISSUE; HOWEVER THE HANDLE APPEARED AS IF IT WAS BROKEN. IT WAS REPORTED THAT THE HANDLE WAS "VERY LOOSE AND NOT RESPONDING." CLINICAL FOLLOW UP REVEALED THAT THERE WAS NO VISIBLE ISSUE WITH THE DEVICE. THE CLIP WAS ADVANCED FROM THE OVERSHEATH USING THE BLUE GRIP; HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO RELEASE THE CLIP FROM THE CATHETER, IT WOULD NOT RELEASE AND REMAINED ATTACHED TO THE CONTROL WIRE. ALTHOUGH THE CLIP WAS ATTACHED TO TISSUE WHEN IT FAILED TO RELEASE FROM THE CATHETER, IT RELEASED FROM THE TISSUE WITHOUT COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP AND THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522610 10111701C2

    Patients

    Seq Age Sex Outcome Treatment
    1