BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 2143354 · Received June 29, 2011

    Report

    Report Number
    3005099803-2011-02212
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Report Date
    June 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IS OVER 18 YEARS OLD. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRATION DATE. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF SEVEN COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #'S 3005099803-2011-02212, 3005099803-2011-02213, 3005099803-2011-02214, 3005099803-2011-02215, 3005099803-2011-02216, 3005099803-2011-02217 AND 3005099803-2011-02218. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SEVEN RESOLUTION HEMOSTASIS CLIPPING DEVICES WERE USED TO TREAT A POST-POLYPECTOMY BLEED IN THE COLON DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ALL SEVEN RESOLUTION CLIPS WOULD NOT SEPARATE FROM THE DELIVERY CATHETER AFTER DEPLOYMENT. THE PHYSICIAN HAD TO PULL EACH CLIP OFF THE TISSUE IN ORDER TO REMOVE THE DEVICE FROM THE PATIENT. THIS MANIPULATION DID NOT RESULT IN ADDITIONAL BLEEDING OR TISSUE DAMAGE. AN EIGHT RESOLUTION CLIP WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT COMPLICATIONS. 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 HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522612

    Patients

    Seq Age Sex Outcome Treatment
    1