BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1893436 · Received November 8, 2010

    Report

    Report Number
    3005099803-2010-04607
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    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

    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 DEVICE. BASED ON THE EVALUATION CONDUCTED AND THE DETAILS OF THE COMPLAINT, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT AS THE CLIP FAILING TO RELEASE FROM THE CATHETER MAY HAVE BEEN DUE TO ANATOMICAL OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. 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.

    Additional Manufacturer Narrative · 1

    PATIENT IS (B)(6). 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.

    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 GASTROSCOPY PROCEDURE IN THE STOMACH. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP FAILED TO DEPLOY CORRECTLY AND REMAINED ATTACHED TO THE CATHETER. THE DEVICE DID NOT GRASP TISSUE AND WAS REMOVED FROM THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN "STABLE" CONDITION 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 GASTROSCOPY PROCEDURE IN THE STOMACH. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP FAILED TO DEPLOY CORRECTLY AND REMAINED ATTACHED TO THE CATHETER. THE DEVICE DID NOT GRASP TISSUE AND WAS REMOVED FROM THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN "STABLE" CONDITION POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 0ML9122106

    Patients

    Seq Age Sex Outcome Treatment
    1