BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2961837 · Received February 14, 2013

    Report

    Report Number
    3005099803-2013-00626
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS" VISUAL EXAMINATION NOTED THAT THE CLIP ASSEMBLY WAS MASHED ONTO THE BUSHING. IT WAS ALSO NOTED THAT THE SLIDER COVER AND CROSS PIN WERE DETACHED. FUNCTIONAL ANALYSIS REVEALED THAT THE CLIP ASSEMBLY COULD NOT BE DEPLOYED AND THE PRONGS COULD NOT BE OPENED OR CLOSED. THE PRONGS WERE NOT LOCKED INTO THE CAPSULE. ACCORDING TO THE COMPLAINANT, THE CLIP WAS DIFFICULT TO RELEASE FROM THE CATHETER. HOWEVER, THE INVESTIGATION FOUND THE CLIP MASHED ONTO THE BUSHING AND NOT ABLE TO BE DEPLOYED. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE REPORTED FAILURE COULD NOT BE CONFIRMED. THE COMPLAINT WAS NOT CONFIRMED AS THE CLIP COULD NOT BE RELEASED FROM THE CATHETER. 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.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4) FOR THE REPORTED EVENT OF CLIP DIFFICULT TO RELEASE FROM CATHETER. 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 AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON A DUODENAL ULCER WITH CLOT PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, AFTER THE RESOLUTION CLIP DEVICE WAS ADVANCED TO THE TARGET TISSUE, THE CLIP ASSEMBLY WAS LOCKED AND DEPLOYED; HOWEVER, THE CLIP FAILED TO RELEASE FROM THE DELIVERY CATHETER. THE CLIP ASSEMBLY SEPARATED AFTER OPENING AND CLOSING THE DEVICE ONCE AGAIN, BUT A "SMALL PIECE OF CLIP BROKE" OFF IN THE PATIENT'S COLON. THE PIECE WAS ALLOWED TO FLUSH OUT NATURALLY. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON A DUODENAL ULCER WITH CLOT PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, AFTER THE RESOLUTION CLIP DEVICE WAS ADVANCED TO THE TARGET TISSUE, THE CLIP ASSEMBLY WAS LOCKED AND DEPLOYED; HOWEVER, THE CLIP FAILED TO RELEASE FROM THE DELIVERY CATHETER. THE CLIP ASSEMBLY SEPARATED AFTER OPENING AND CLOSING THE DEVICE ONCE AGAIN, BUT A "SMALL PIECE OF CLIP BROKE" OFF IN THE PATIENT'S COLON. THE PIECE WAS ALLOWED TO FLUSH OUT NATURALLY. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64728 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522612 ML000358C3

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR