BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2874357 · Received December 14, 2012

    Report

    Report Number
    3005099803-2012-05965
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 22, 2012
    Report Date
    November 22, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT PATIENT AGE IS UNKNOWN BUT IS OVER 18 YEARS. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND DEVICE MANUFACTURED DATES ARE UNKNOWN. (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 FOUND THAT THE DEVICE RETURNED WITH THE CLIP ASSEMBLY WAS LOCATED JUST INSIDE THE OVERSHEATH. THE BLUE SHEATH GRIP WAS PULLED BACK AND THE CLIP ASSEMBLY WAS ACTUATED AND DEPLOYED; TWO DISTINCTIVE CLICKS WERE HEARD. THE PRONGS, WHICH WERE BENT, OPENED TO APPROXIMATELY 9MM. ADDITIONALLY, A KINK IN THE CONTROL WIRE WAS NOTICED. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE CLIP FAILED TO RELEASE FROM THE DELIVERY CATHETER. HOWEVER, THE EVENT MAY HAVE OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMANCE AS IS EVIDENT BY THE KINK IN THE CONTROL WIRE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2012-05965 AND 3005099803-2012-05966 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIP DEVICES WERE TO BE USED FOR HEMOSTASIS DURING A RECTAL PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING THE RESOLUTION CLIP (MFR # 3005099803-2012-05965) THROUGH THE ENDOSCOPE. THE DEVICE EVENTUALLY EXITED THE SCOPE; HOWEVER, DURING DEPLOYMENT, THE CLIP ASSEMBLY FAILED TO SEPARATE FROM THE DELIVERY CATHETER. THE DEVICE WAS WITHDRAWN FROM THE PATIENT, AND THEN A SECOND RESOLUTION CLIP (MFR # 3005099803-2012-05966) WAS USED, BUT A "SIMILAR ISSUE OCCURRED". IT IS NOT CURRENTLY KNOWN IF THIS REFLECTS A FAILURE TO RELEASE SCENARIO, DIFFICULTY ADVANCING THE DEVICE THROUGH THE SCOPE, OR A COMBINATION OF THE TWO. REPORTEDLY, THE PROCEDURE WAS ABLE TO BE COMPLETED USING A THIRD RESOLUTION CLIP DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2012-05965 AND 3005099803-2012-05966 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIP DEVICES WERE TO BE USED FOR HEMOSTASIS DURING A RECTAL PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING THE RESOLUTION CLIP (MR # 3005099803-2012-05965) THROUGH THE ENDOSCOPE. THE DEVICE EVENTUALLY EXITED THE SCOPE; HOWEVER, DURING DEPLOYMENT, THE CLIP ASSEMBLY FAILED TO SEPARATE FROM THE DELIVERY CATHETER. THE DEVICE WAS WITHDRAWN FROM THE PATIENT, AND THEN A SECOND RESOLUTION CLIP (MR # 3005099803-2012-05966) WAS USED, BUT A 'SIMILAR ISSUE OCCURRED.' IT IS NOT CURRENTLY KNOWN IF THIS REFLECTS A FAILURE TO RELEASE SCENARIO, DIFFICULTY ADVANCING THE DEVICE THROUGH THE SCOPE, OR A COMBINATION OF THE TWO. REPORTEDLY, THE PROCEDURE WAS ABLE TO BE COMPLETED USING A THIRD RESOLUTION CLIP DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1