BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2891070 · Received December 31, 2012

    Report

    Report Number
    3005099803-2012-06363
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF CLIP FAILED 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE CLIP ASSEMBLY FULLY DEPLOYED AND NOT RETURNED. THE CONTROL WIRE WAS SEPARATED PER DESIGN. ADDITIONALLY, A KINK WAS PRESENT IN THE CONTROL WIRE. THE COMPLAINT OF CLIP FAILURE TO RELEASE FROM CATHETER WAS NOT ABLE TO BE CONFIRMED SINCE THE DEVICE WAS RECEIVED WITH THE CLIP ASSEMBLY FULLY DEPLOYED. HOWEVER, THE EVENT MAY HAVE OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMANCE AS EVIDENCED BY THE KINK IN THE CONTROL WIRE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DESIGN HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WAS LOCKED ONTO A POLYP BUT FAILED TO RELEASE FROM THE DELIVERY CATHETER. THE CLIP WAS PULLED OFF OF THE POLYP AND REMOVED FROM THE PATIENT AND FROM SERVICE. THE CLIP WAS TESTED OUTSIDE OF THE PATIENT AND DEPLOYED NORMALLY. THE PROCEDURE WAS COMPLETED USING A SECOND RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING 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 PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WAS LOCKED ONTO A POLYP BUT FAILED TO RELEASE FROM THE DELIVERY CATHETER. THE CLIP WAS PULLED OFF OF THE POLYP AND REMOVED FROM THE PATIENT AND FROM SERVICE. THE CLIP WAS TESTED OUTSIDE OF THE PATIENT AND DEPLOYED NORMALLY. THE PROCEDURE WAS COMPLETED USING A SECOND RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 ML000368C3

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR