BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1881255 · Received October 25, 2010

    Report

    Report Number
    3005099803-2010-04437
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Report Date
    October 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE CLIP ASSEMBLY WAS DEPLOYED, AS THE CONTROL WIRE WAS SEPARATED PER DESIGN; HOWEVER THE DEPLOYED CLIP ASSEMBLY WAS FOUND TO BE MASHED ONTO THE BUSHING. THE OVER SHEATH WAS NOT RETURNED WITH THE DEVICE. BASED ON THE EVALUATION CONDUCTED AND THE DETAILS OF THE COMPLAINT, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT. THE DAMAGE TO THE CLIP ASSEMBLY MAY HAVE BEEN A RESULT OF ANATOMICAL OR PROCEDURAL FACTORS THAT WERE 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.

    Additional Manufacturer Narrative · 1

    PATIENT IS OVER 18 YEARS OLD. ALTHOUGH THE EXACT EVENT DATE IS UNKNOWN, IT WAS REPORTED THAT THE EVENT OCCURRED A "COUPLE OF WEEKS AGO." COMPONENT CODE (758) RELATES TO DEVICE CODE (2541) FOR THE REPORTED EVENT OF CLIP FAILED TO DISCONNECT FROM CATHETER. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE RESOLUTION CLIP WAS POSITIONED WITHIN THE PATIENT'S COLON. THE CLIP ADVANCED FROM THE OVER SHEATH, HOWEVER THE CLIP FAILED TO OPEN AND WOULD NOT RELEASE FROM THE CATHETER. A SECOND RESOLUTION CLIP WAS USED TO COMPLETE THE PROCEDURE WITHOUT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE "FINE" POST PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE RESOLUTION CLIP WAS POSITIONED WITHIN THE PATIENT'S COLON. THE CLIP ADVANCED FROM THE OVER SHEATH, HOWEVER THE CLIP FAILED TO OPEN AND WOULD NOT RELEASE FROM THE CATHETER. A SECOND RESOLUTION CLIP WAS USED TO COMPLETE THE PROCEDURE WITHOUT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE "FINE" POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522612 10012708C2

    Patients

    Seq Age Sex Outcome Treatment
    1