BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1611498 · Received February 22, 2010

    Report

    Report Number
    3005099803-2010-00652
    Event Type
    Malfunction
    Date Received
    February 22, 2010
    Date of Event
    January 7, 2010
    Report Date
    January 28, 2010
    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).

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND MANUFACTURE DATES ARE UNKNOWN.THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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.BSC REFERENCE: A00204328 / 1422507

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION, IT WAS NOTED THAT THE SHEATH GRIP WAS DETACHED FROM THE OVER SHEATH, AND THAT THERE WAS A KINK NEAR THE HANDLE. THE CLIP ASSEMBLY COULD NOT BE ACTUATED, BUT COULD BE DEPLOYED. IT WAS ALSO NOTED THAT THE CLIP ASSEMBLY WAS OUTSIDE THE OVER SHEATH. AS EVIDENT BY THE KINK IN THE CONTROL WIRE AND THE SHEATH GRIP BEING DETACHED, THE END-USER MAY HAVE EXCEEDED THE DESIGN LIMITS OF THE DEVICE DURING USE. THIS INVESTIGATION WILL BE ASSIGNED THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING AN UNKNOWN TYPE OF PROCEDURE. ACCORDING TO THE COMPLAINANT, IT WAS IMPOSSIBLE TO REMOVE THE CLIP FROM THE SHEATH. ANOTHER RESOLUTION CLIP WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION: PROCEDURE WAS PREFORMED IN THE COLON, AND WAS A PREVENTIVE ACTION FOR AVK (ANTIVITAMIN K). NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING AN UNKNOWN TYPE OF PROCEDURE. ACCORDING TO THE COMPLAINANT, IT WAS IMPOSSIBLE TO REMOVE THE CLIP FROM THE SHEATH. ANOTHER RESOLUTION CLIP WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: PROCEDURE WAS PREFORMED IN THE COLON, AND WAS A PREVENTIVE ACTION FOR AVK (ANTIVITAMIN K). NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 0ML8092209

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR