BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3242306 · Received July 23, 2013

    Report

    Report Number
    3005099803-2013-06142
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF OVER SHEATH TORN. INVESTIGATION RESULTS: VISUAL EXAMINATION NOTED THAT THE DEVICE WAS FULLY DEPLOYED. THE CLIP ASSEMBLY WAS RETURNED INSIDE THE PACKAGE. THE CAPSULE TABS WERE PARTIALLY OPEN AND THE OVER SHEATH WAS TORN AT THE DISTAL END. FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE CLIP ASSEMBLY WAS RETURNED FULLY DEPLOYED FROM THE DELIVERY SYSTEM. INVESTIGATION FOUND THE COMPLAINT DEVICE WAS RETURNED FULLY DEPLOYED AND THE OVER SHEATH WAS TORN AT THE DISTAL END. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE REPORTED FAILURE (CLIP DEPLOYED PREMATURELY) COULD NOT BE CONFIRMED AND THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2013 THAT A RESOLUTION CLIP DEVICE WAS USED FOR HEMOSTASIS DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP PREMATURELY DEPLOYED BEFORE IT WAS ATTACHED TO THE TISSUE. THE CLIP FELL INTO THE PATIENT AND WAS RETRIEVED WITH AN UNKNOWN DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS FINE. INVESTIGATION RESULTS REVEALED THAT THE OVER SHEATH WAS TORN NEAR THE DISTAL TIP, THEREFORE THIS IS NOW AN MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343887 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 ML000449C3

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR