BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 2070532 · Received April 27, 2011

    Report

    Report Number
    3005099803-2011-01478
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 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

    (B)(4):THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT 3005099803-2011-01476 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIP DEVICES WERE USED DURING A COLONOSCOPY PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IN BOTH INSTANCES, THE CLIP WERE ATTACHED TO THE TARGET SITE HOWEVER, THE CLIPS WOULD NOT RELEASE FROM THE CATHETER. THE PHYSICIAN "JIGGLED" THE DEVICE, TRYING TO RELEASE THE CLIP, AND AFTER SEVERAL ATTEMPTS THE CLIPS FELL INTO THE PATIENT IN A CLOSED STATE. IT WAS REPORTED THAT THERE WAS NO TISSUE DAMAGE OR BLEEDING CAUSED BY THIS EVENT. IT WAS ALSO REPORTED THAT THE CLIPS WERE LEFT TO PASS NATURALLY. THE CASE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 11012004C2

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR