BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1892944 · Received November 8, 2010

    Report

    Report Number
    3005099803-2010-04608
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS REPORTED TO BE (B)(6) OLD. 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.

    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. IT WAS ALSO NOTICED THAT THE SHEATH GRIP WAS DETACHED FROM THE OVER SHEATH. THE SLIDE COVER WAS PARTIALLY REMOVED AND THE CONTROL WIRE WAS PULLED OUT. IT WAS ALSO NOTICED THAT THE COIL WAS STRETCHED AND CUT APPROXIMATELY 10" FROM THE HANDLE. BASED ON THE EVALUATION CONDUCTED AND THE DETAILS OF THE COMPLAINT, THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS OPERATIONAL CONTEXT. THE DAMAGE TO THE DEVICE MAY HAVE BEEN A RESULT OF ANATOMICAL OR 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 ON (B)(6), 2010 THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE TO TREAT A DIVERTICULAR BLEED IN THE COLON. ACCORDING TO THE COMPLAINANT, DURING THE COLONOSCOPY PROCEDURE, THE RESOLUTION CLIP WAS ADVANCED DOWN THE COLONOSCOPE AND POSITIONED WITHIN THE COLON AT THE TARGET SITE. THE CLIP GRASPED TISSUE AND WAS LOCKED CLOSED. HOWEVER, THE CLIP FAILED TO RELEASE FROM THE DELIVERY CATHETER. DURING MANIPULATION OF THE DEVICE IN AN ATTEMPT TO DEPLOY THE CLIP, THE CLOSED CLIP PULLED OFF FROM THE TISSUE. NO TRAUMA WAS CAUSED TO THE TISSUE AT THE CLIPPING SITE WHEN THE CLIP WAS PULLED OFF. THE CLIP WAS RETRACTED BACK INTO THE OVER SHEATH AND THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT. A SECOND RESOLUTION CLIP WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT COMPLICATIONS. THE COLONOSCOPE WAS NOT IN A RETROFLEX POSITION AND THE DELAY IN PROCEDURE AS A RESULT OF THIS EVENT WAS ESTIMATED TO BE 5-10 MINUTES. THIS DELAY DID NOT EXACERBATE THE BLEED. 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 TO TREAT A DIVERTICULAR BLEED IN THE COLON. ACCORDING TO THE COMPLAINANT, DURING THE COLONOSCOPY PROCEDURE, THE RESOLUTION CLIP WAS ADVANCED DOWN THE COLONOSCOPE AND POSITIONED WITHIN THE COLON AT THE TARGET SITE. THE CLIP GRASPED TISSUE AND WAS LOCKED CLOSED. HOWEVER, THE CLIP FAILED TO RELEASE FROM THE DELIVERY CATHETER. DURING MANIPULATION OF THE DEVICE IN AN ATTEMPT TO DEPLOY THE CLIP, THE CLOSED CLIP PULLED OFF FROM THE TISSUE. NO TRAUMA WAS CAUSED TO THE TISSUE AT THE CLIPPING SITE WHEN THE CLIP WAS PULLED OFF. THE CLIP WAS RETRACTED BACK INTO THE OVER SHEATH AND THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT. A SECOND RESOLUTION CLIP WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT COMPLICATIONS. THE COLONOSCOPE WAS NOT IN A RETROFLEX POSITION AND THE DELAY IN PROCEDURE AS A RESULT OF THIS EVENT WAS ESTIMATED TO BE 5-10 MINUTES. THIS DELAY DID NOT EXACERBATE THE BLEED. 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 M00522610 10080206C2

    Patients

    Seq Age Sex Outcome Treatment
    1