BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1910178 · Received November 30, 2010

    Report

    Report Number
    3005099803-2010-04917
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE CLIP ASSEMBLY WAS FULLY DEPLOYED, AS THE CONTROL WIRE WAS SEPARATED PER DESIGN, AND WAS NOT RETURNED WITH THE DELIVERY CATHETER. IT WAS ALSO NOTICED THAT THE OVER SHEATH WAS TORN AND STRETCHED. ALTHOUGH THE EVENT OF "CLIP FAILED TO RELEASE FROM CATHETER" COULD NOT BE CONFIRMED, IT IS LIKELY THAT THIS FAILURE, IN ADDITION TO THE DAMAGE FOUND TO THE DEVICE, RESULTED FROM ANATOMICAL OR PROCEDURAL FACTORS THAT WERE ENCOUNTERED DURING THE PROCEDURE; THEREFORE, THE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A RESOLUTION CLIP DEVICE WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, RESISTANCE WAS MET AND THEY COULD NOT GET THE CLIP TO RELEASE FROM THE CATHETER. THE CLIP WAS OPENED AND REMOVED FROM THE TISSUE WITHOUT COMPLICATIONS. THE ENTIRE DEVICE (CLIP AND DELIVERY CATHETER) WAS REMOVED FROM THE PATIENT. OUTSIDE OF THE PATIENT, THE NURSE APPLIED EXCESSIVE FORCE TO THE HANDLE AND THE CLIP FINALLY POPPED OFF THE END OF THE DELIVERY CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS REPORTED TO BE "FINE" POST PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2010 THAT A RESOLUTION CLIP DEVICE WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, RESISTANCE WAS MET AND THEY COULD NOT GET THE CLIP TO RELEASE FROM THE CATHETER. THE CLIP WAS OPENED AND REMOVED FROM THE TISSUE WITHOUT COMPLICATIONS. THE ENTIRE DEVICE (CLIP AND DELIVERY CATHETER) WAS REMOVED FROM THE PATIENT. OUTSIDE OF THE PATIENT, THE NURSE APPLIED EXCESSIVE FORCE TO THE HANDLE AND THE CLIP FINALLY POPPED OFF THE END OF THE DELIVERY CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 M00522610 10072706C2

    Patients

    Seq Age Sex Outcome Treatment
    1