BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1894415 · Received November 9, 2010

    Report

    Report Number
    3005099803-2010-04649
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Report Date
    October 19, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. BASED ON THE DETAILS OF THE COMPLAINT, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. THE FAILURE OF THE CLIP TO RELEASE FROM THE CATHETER IS MOST LIKELY DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE SECOND OF THREE COMPLAINTS THAT INVOLVE THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT#'S 3005099803-2010-04648 AND 3005099803-2010-04650 FOR THE ASSOCIATED DEVICE REPORTS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2010 THAT THREE RESOLUTION CLIP DEVICES WERE USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE RESOLUTION CLIP PREMATURELY LOCKED CLOSED AND FAILED TO DEPLOY FROM THE DELIVERY CATHETER. THE TECHNICIAN WAS UNABLE TO RETRACT THE CLIP BACK INTO THE SHEATH. THE CLIP DEVICE WAS REMOVED FROM THE PATIENT AND NO VISIBLE DAMAGE WAS NOTED TO THE DEVICE. THIS ISSUE WAS ENCOUNTERED WITH A TOTAL OF THREE RESOLUTION CLIPS DURING THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ADDITIONAL RESOLUTION CLIPS. THE COMPLAINANT REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 10050501C2

    Patients

    Seq Age Sex Outcome Treatment
    1