BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3011191 · Received March 19, 2013

    Report

    Report Number
    3005099803-2013-01293
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED ISSUE OF CLIP WON'T DETACH FROM THE CATHETER THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    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, AFTER ADVANCING THE DEVICE THROUGH THE SCOPE AND TO THE TARGET LOCATION IN THE PATIENT'S BOWELS; DEPLOYMENT WAS ATTEMPTED. REPORTEDLY, THE CLIP ASSEMBLY WAS OPENED, CLOSED, AND THEN DEPLOYED WITH TWO DISTINCT CLICKS BEING AUDIBLE; HOWEVER, THE CLIP ASSEMBLY FAILED TO RELEASE FROM THE DELIVERY CATHETER. THE RESOLUTION CLIP DEVICE WAS WITHDRAWN FROM THE PATIENT, AND THEN THE PROCEDURE WAS COMPLETED USING AN INJECTION NEEDLE. POST PROCEDURE, WHILE THE SCOPE WAS BEING CLEANED, THE CLIP WAS FOUND. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114743 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 ML000328C3

    Patients

    Seq Age Sex Outcome Treatment
    1