BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1222873 · Received November 6, 2008

    Report

    Report Number
    3005099803-2008-06107
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED: THE CATHETER OUTER SHEATH EXTENDED BEYOND THE EXPOSED CLIP; THE SHEATH GRIP WAS DETACHED FROM THE OVER SHEATH; AND THE CLIP ASSEMBLY WAS LOCATED APPROXIMATELY 2 INCHES INSIDE THE OVER SHEATH. A FUNCTIONAL EVALUATION WAS CONDUCTED BY MANUALLY GRASPING THE OVER SHEATH; THE CLIP ASSEMBLY COULD BE EXPOSED. ONCE THE CLIP ASSEMBLY WAS EXPOSED, IT WAS ACTUATED SEVERAL TIMES AND, THEN DEPLOYED AS INTENDED BY DESIGN. BASED ON THE PHYSICAL CONDITION OF THE RETURNED DEVICE AND THE FUNCTIONAL EVALUATION, THE REPORTED MALFUNCTION IS ATTRIBUTED TO OPERATIONAL CONTEXT (PROCEDURAL USE). A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PERTINENT LOT WAS PERFORMED; NO ANOMALIES WERE NOTED. THE SEPTEMBER 2008 15-MONTH HEMOSTATIC CLIPPING PRODUCT FAMILY COMPLAINT TREND REPORT WAS REVIEWED; NO UNFAVORABLE TRENDS WERE NOTED FOR THE FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WOULD NOT DEPLOY. THE PROCEDURE 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 CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522612 0ML8052802

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR