BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1981698 · Received February 8, 2011

    Report

    Report Number
    3005099803-2011-00287
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. 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 THAT THERE WAS A KINK IN THE CONTROL WIRE. THE CLIP ASSEMBLY WAS FULLY DEPLOYED AND WAS NOT RETURNED WITH THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. BASED ON THE EVALUATION CONDUCTED AND THE DETAILS OF THE COMPLAINT, IT IS PROBABLE THAT THE FAILURE OF THE CLIP TO RELEASE FROM THE CATHETER WAS DUE TO ANATOMICAL OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE; THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2011-00286 FOR THE ASSOCIATED DEVICE REPORT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2011 THAT TWO RESOLUTION HEMOSTATIC CLIPPING DEVICES WERE USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST RESOLUTION CLIP GRASPED TISSUE BUT WOULD NOT RELEASE FROM THE CATHETER NOR WOULD IT STAY ATTACHED TO THE TISSUE. NOTHING FELL INTO THE PATIENT AND THE ENTIRE CLIPPING DEVICE WAS REMOVED FROM THE PATIENT. THE SAME ISSUE OCCURRED WITH A SECOND RESOLUTION CLIP USED DURING THIS PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A THIRD RESOLUTION CLIP WITHOUT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE "WELL" AT THE CONCLUSION OF THE PROCEDURE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2011-00286 FOR THE ASSOCIATED DEVICE REPORT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT TWO RESOLUTION HEMOSTATIC CLIPPING DEVICES WERE USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST RESOLUTION CLIP GRASPED TISSUE BUT WOULD NOT RELEASE FROM THE CATHETER NOR WOULD IT STAY ATTACHED TO THE TISSUE. NOTHING FELL INTO THE PATIENT AND THE ENTIRE CLIPPING DEVICE WAS REMOVED FROM THE PATIENT. THE SAME ISSUE OCCURRED WITH A SECOND RESOLUTION CLIP USED DURING THIS PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A THIRD RESOLUTION CLIP WITHOUT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE "WELL" AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 10051101C2

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR