BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3981799 · Received August 5, 2014

    Report

    Report Number
    3005099803-2014-02698
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOG
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    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 FOUND THE CLIP DETACHED FROM THE BUSHING BUT STILL ATTACHED TO THE CONTROL WIRE VIA THE TENSION BREAKER AND YOKE. THE PRONGS COULD NOT BE OPENED; HOWEVER, THE CLIP ASSEMBLY WAS ABLE TO BE DEPLOYED, TWO CLICKS WERE HEARD. IT WAS ALSO NOTED THAT THE CAPSULE TABS WERE PARTIALLY OPEN. THE COMPLAINT THAT THE CLIP WON'T OPEN WAS CONFIRMED; HOWEVER, INVESTIGATION COULD NOT CONFIRM THE REPORTED EVENT OF CLIP UNABLE TO RELEASE FROM THE CATHETER. 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) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WOULD NOT OPEN. ANOTHER ATTEMPT TO OPEN THE CLIP WAS DONE, THIS TIME WITH ADDITIONAL PRESSURE WAS APPLIED TO DEPLOY THE CLIP. HOWEVER, THE CLIP FAILED TO RELEASE FROM THE CATHETER. THE CLIP WAS NOT ABLE TO GRASP ANY TISSUE AT ALL AND WAS REMOVED OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WOULD NOT OPEN. ANOTHER ATTEMPT TO OPEN THE CLIP WAS DONE, THIS TIME WITH ADDITIONAL PRESSURE WAS APPLIED TO DEPLOY THE CLIP. HOWEVER, THE CLIP FAILED TO RELEASE FROM THE CATHETER. THE CLIP WAS NOT ABLE TO GRASP ANY TISSUE AT ALL AND WAS REMOVED OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. 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
    458123 RESOLUTION CLIP CLIPPING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH M00522610 ML000678C3

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR