BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2894149 · Received January 3, 2013

    Report

    Report Number
    3005099803-2012-06374
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT PATIENT AGE IS UNKNOWN HOWEVER; IT HAS BEEN REPORTED THAT THE PATIENT IS OVER 18. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. THE COMPLAINANT INDICATED THAT THE DEVICE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED POST POLYPECTOMY DURING A COLONOSCOPY PERFORMED ON (B)(6), 2012. ACCORDING TO THE COMPLAINANT, AFTER ADVANCING THE RESOLUTION CLIP DEVICE THROUGH THE SCOPE, THE CLIP ASSEMBLY WAS LOCKED AND DEPLOYED ONTO THE TARGET TISSUE; HOWEVER, IT FAILED TO RELEASE FROM THE DELIVERY CATHETER. WHEN THE CLIP ASSEMBLY DETACHED FROM THE TISSUE, IT REMAINED ATTACHED TO THE DELIVERY CATHETER. THE DEVICE WAS THEN WITHDRAWN FROM THE PATIENT WITH THE CLIP INTACT, AND THEN REMOVED FROM SERVICE. REPORTEDLY, TWO CLIPS WERE PLACED, WITHOUT ISSUE, PRIOR TO ENCOUNTERING THIS EVENT AND SUFFICIENTLY CONTROLLED THE BLEED SO NO ADDITIONAL INTERVENTION WAS PERFORMED. THEREFORE, THE PROCEDURE WAS COMPLETED USING THE FIRST TWO CLIP ASSEMBLIES DEPLOYED ONTO THE TARGET TISSUE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3589 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522612

    Patients

    Seq Age Sex Outcome Treatment
    1