BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1812329 · Received August 24, 2010

    Report

    Report Number
    3005099803-2010-03637
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Report Date
    August 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE THIRD OF THREE COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #S 3005099803-2010-03635 AND 3005099803-2010-03636. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2010 THAT THREE RESOLUTION CLIP DEVICES WERE USED DURING A PROCEDURE ON A PATIENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THREE CLIPS DID NOT FULLY DETACH FROM THE CATHETER WHEN THEY WERE DEPLOYED INSIDE THE PATIENT; HOWEVER, WHEN THE NURSE PULLED ON THE CATHETER, THE CLIPS FELL OFF THE TISSUE AND CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURERS' DEVICE WITH NO PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE "FINE" 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 10032908C2

    Patients

    Seq Age Sex Outcome Treatment
    1