BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3781008 · Received April 30, 2014

    Report

    Report Number
    3005099803-2014-01800
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 10, 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

    A VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE CLIP ASSEMBLY FULLY DEPLOYED AND NOT RETURNED. THERE WAS A KINK IN THE CONTROL WIRE. THE SHEATH GRIP WAS DETACHED FROM THE OVER SHEATH. THE OVER SHEATH WAS CUT AT THE DISTAL END AND APPROXIMATELY 13 INCHES OF THE OVER SHEATH WAS NOT RETURNED. IT WAS ALSO NOTED THAT THE CROSS PIN WAS SEPARATED FROM THE SLIDER BUT STILL ATTACHED TO 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. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF CLIP FAILED TO RELEASE FROM THE 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2014-01799 AND MANUFACTURER REPORT # 3005099803-2014-01800 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO HEMOSTATIC CLIPPING DEVICES WERE USED DURING AN ENDOSCOPIC PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST CLIP OPENED AND CLOSED BUT FAILED TO RELEASE FROM THE CATHETER. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PHYSICIAN ATTEMPTED TO USE A SECOND CLIP BUT THE SAME ISSUE OCCURRED AND THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2014-01799 AND MANUFACTURER REPORT # 3005099803-2014-01800 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO HEMOSTATIC CLIPPING DEVICES WERE USED DURING AN ENDOSCOPIC PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST CLIP OPENED AND CLOSED BUT FAILED TO RELEASE FROM THE CATHETER. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PHYSICIAN ATTEMPTED TO USE A SECOND CLIP BUT THE SAME ISSUE OCCURRED AND THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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
    260466 RESOLUTION CLIP CLIPPING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH M00522611 ML000650C3

    Patients

    Seq Age Sex Outcome Treatment
    1