BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 2063312 · Received April 19, 2011

    Report

    Report Number
    3005099803-2011-01339
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF CLIP FAILED TO RELEASE FROM CATHETER. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE SHEATH GRIP WAS DETACHED FROM THE OVER SHEATH AND THERE WAS A KINK IN THE CONTROL WIRE. THE CLIP ASSEMBLY WAS LOCATED JUST INSIDE THE OVER SHEATH. FUNCTIONALLY, THE OVER SHEATH WAS PULLED BACK TO EXPOSE THE CLIP ASSEMBLY AND THE CLIP ASSEMBLY WAS THEN DEPLOYED AS DESIGNED. IN ADDITION, TWO CLICKS WERE HEARD. THE REPORTED EVENT OF CLIP FAILED TO RELEASE WAS NOT ABLE TO BE CONFIRMED DUE TO THE CLIP DEPLOYING AS DESIGNED. HOWEVER, THE FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMANCE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS EVIDENT BY THE KINK IN THE CONTROL WIRE AND THE SHEATH GRIP BEING DETACHED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION HEMOSTASIS CLIPPING DEVICE WAS USED DURING A PROCEDURE IN THE SIGMOID COLON. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP FAILED TO RELEASE FROM THE CATHETER. WHEN THIS ISSUE WAS ENCOUNTERED, THE CLIP WAS NOT ATTACHED TO PATIENT TISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION HEMOSTASIS CLIPPING 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 AS BEING OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION HEMOSTASIS CLIPPING DEVICE WAS USED DURING A PROCEDURE IN THE SIGMOID COLON. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP FAILED TO RELEASE FROM THE CATHETER. WHEN THIS ISSUE WAS ENCOUNTERED, THE CLIP WAS NOT ATTACHED TO PATIENT TISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION HEMOSTASIS CLIPPING 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 AS BEING OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 11020703C2

    Patients

    Seq Age Sex Outcome Treatment
    1