BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2931911 · Received January 28, 2013

    Report

    Report Number
    3005099803-2013-00357
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE DEVICE WAS FULLY DEPLOYED AND THE CLIP ASSEMBLY WAS NOT RETURNED. 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. THE COMPLAINT DEVICE WAS RETURNED FULLY DEPLOYED AND THE CLIP ASSEMBLY WAS NOT RETURNED. THE MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED DUE TO THE RETURN CONDITION OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    EXACT PATIENT AGE IS UNKNOWN, HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS AROUND (B)(6) YEARS OLD. (B)(4). THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE RESOLUTION CLIP DEVICE WAS LOCKED ONTO TISSUE AND DEPLOYED; HOWEVER, THE CLIP FAILED TO RELEASE FROM THE DELIVERY CATHETER. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SECOND RESOLUTION CLIP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE RESOLUTION CLIP DEVICE WAS LOCKED ONTO TISSUE AND DEPLOYED; HOWEVER, THE CLIP FAILED TO RELEASE FROM THE DELIVERY CATHETER. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SECOND RESOLUTION CLIP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37899 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522610 ML000341C3

    Patients

    Seq Age Sex Outcome Treatment
    1