BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3850861 · Received June 5, 2014

    Report

    Report Number
    3005099803-2014-02170
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOG
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED ISSUE OF CLIP FAILED TO RELEASE FROM CATHETER. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. 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 NOTED THAT THE CLIP ASSEMBLY WAS MASHED ONTO THE BUSHING. THE CLIP ASSEMBLY COULD NOT BE DEPLOYED AND THE PRONGS COULD NOT BE OPENED NOR CLOSED. THE PRONGS WERE NOT LOCKED INTO THE CAPSULE; HOWEVER, THE CLIP HAD AN OVERBITE. IT WAS ALSO NOTED THAT THE SLIDER COVER WAS NOT RETURNED AND THE CROSS PIN WAS SEPARATED FROM THE SLIDER BUT STILL ATTACHED TO THE CONTROL WIRE. A KINK WAS NOTED IN THE CONTROL WIRE. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE REPORTED FAILURE OF CLIP UNABLE TO RELEASE FROM THE CATHETER WAS CONFIRMED. THIS FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE PERFORMANCE OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP GRASPED AND LOCKED ONTO TISSUE; HOWEVER THE CLIP WOULD NOT RELEASE FROM THE CATHETER TO DEPLOY. 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP GRASPED AND LOCKED ONTO TISSUE; HOWEVER, THE CLIP WOULD NOT RELEASE FROM THE CATHETER TO DEPLOY. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330034 RESOLUTION CLIP CLIPPING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH M00522611 ML000710C3

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR