BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1883717 · Received October 27, 2010

    Report

    Report Number
    3005099803-2010-04552
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 7, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS AS OF YET. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE CLIP ASSEMBLY WAS FULLY DEPLOYED AND WAS NOT RETURNED. THE CONTROL WIRE WAS SEPARATED PER DESIGN. IT WAS ALSO NOTICED THAT THERE WAS A KINK IN THE CONTROL WIRE NEAR THE HANDLE. THE MOST PROBABLE ROOT CAUSE HAS BEEN DETERMINED TO BE OPERATIONAL CONTEXT AS EVIDENT BY THE KINK IN THE CONTROL WIRE WHICH WAS MOST LIKELY DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THEY PERFORMED A POLYPECTOMY. THEY POSITIONED THE CLIP ON THE SITE AND DEPLOYED THE CLIP HOWEVER, THE CLIP WOULD NOT RELEASE FROM THE CATHETER. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO MANIPULATE THE CLIP OFF THE SITE. IN ADDITION, IT WAS REPORTED THAT THIS EVENT DID NOT CAUSE ANY BLEEDING OR TISSUE DAMAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF 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 PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THEY PERFORMED A POLYPECTOMY. THEY POSITIONED THE CLIP ON THE SITE AND DEPLOYED THE CLIP HOWEVER, THE CLIP WOULD NOT RELEASE FROM THE CATHETER. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO MANIPULATE THE CLIP OFF THE SITE. IN ADDITION, IT WAS REPORTED THAT THIS EVENT DID NOT CAUSE ANY BLEEDING OR TISSUE DAMAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF 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
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522610 0ML9091805

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR