BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3822423 · Received May 20, 2014

    Report

    Report Number
    3005099803-2014-01847
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    April 24, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOG
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT AGE OF THE PATIENT IS UNKNOWN; HOWEVER, IT WAS REPORTED THE PATIENT WAS OVER 18 YEARS. THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. (B)(4) FOR THE REPORTED ISSUE OF CLIP FAILED TO RELEASE FROM CATHETER. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 NOTED THAT THE CLIP ASSEMBLY WAS FULLY DEPLOYED AND NOT RETURNED. THE CONTROL WIRE WAS SEPARATED PER DESIGN. A KINK WAS NOTED IN THE CONTROL WIRE. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE REPORTED FAILURE COULD NOT BE CONFIRMED. HOWEVER, IT IS LIKELY THAT THE DIFFICULTIES EXPERIENCED DURING DEPLOYMENT WERE DUE TO ANATOMICAL OR PROCEDURAL FACTORS SUCH AS TORTUOUS ANATOMY OR MANEUVERING OF THE DEVICE. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #S 3005099803-2014-01845, 3005099803-2014-01846, AND 3005099803-2014-01847 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE RESOLUTION CLIP DEVICES WERE USED IN A PROCEDURE. (EXACT DATE UNKNOWN) ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THREE HEMOSTATIC CLIPS GRASPED AND LOCKED ONTO TISSUE; HOWEVER, THE CLIPS FAILED TO RELEASE FROM THE CATHETER. ANOTHER RESOLUTION CLIP WAS USED TO COMPLETE THE PROCEDURE. 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 STABLE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #S 3005099803-2014-01845, 3005099803-2014-01846, AND 3005099803-2014-01847 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE RESOLUTION CLIP DEVICES WERE USED IN A PROCEDURE. (EXACT DATE UNKNOWN) ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THREE HEMOSTATIC CLIPS GRASPED AND LOCKED ONTO TISSUE; HOWEVER, THE CLIPS FAILED TO RELEASE FROM THE CATHETER. ANOTHER RESOLUTION CLIP WAS USED TO COMPLETE THE PROCEDURE. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299698 RESOLUTION CLIP CLIPPING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH M00522610

    Patients

    Seq Age Sex Outcome Treatment
    1