BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1934071 · Received December 21, 2010

    Report

    Report Number
    3005099803-2010-05249
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 26, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE CLIP ASSEMBLY WAS FULLY DEPLOYED, AS THE CONTROL WIRE WAS SEPARATED PER DESIGN, AND WAS NOT RETURNED WITH THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR LOT # 10070106C2 FOR THE REPORTED EVENT. 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.

    Additional Manufacturer Narrative · 1

    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 MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A RESOLUTION CLIP DEVICE WAS USED DURING A PROCEDURE TO TREAT A HEMORRHAGIC LESION ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST CLIP WAS PLACED SUCCESSFULLY. A SECOND CLIP (THE SUBJECT OF THIS REPORT) WAS INSERTED INTO THE WORKING CHANNEL OF THE ENDOSCOPE AND ADVANCED TO THE TARGET LESION. THE CLIP OPENED BUT COULD NOT BE RELEASED FROM THE DELIVERY CATHETER. THE ENTIRE CLIPPING DEVICE WAS REMOVED FROM THE ENDOSCOPE AND A THIRD RESOLUTION CLIP WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT COMPLICATIONS. SEVERAL ATTEMPTS TO ASCERTAIN FURTHER DETAILS (INCLUDING PATIENT INFORMATION AND FOLLOW-UP PROCEDURE INFORMATION) HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A RESOLUTION CLIP DEVICE WAS USED DURING A PROCEDURE TO TREAT A HEMORRHAGIC LESION ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST CLIP WAS PLACED SUCCESSFULLY. A SECOND CLIP (THE SUBJECT OF THIS REPORT) WAS INSERTED INTO THE WORKING CHANNEL OF THE ENDOSCOPE AND ADVANCED TO THE TARGET LESION. THE CLIP OPENED BUT COULD NOT BE RELEASED FROM THE DELIVERY CATHETER. THE ENTIRE CLIPPING DEVICE WAS REMOVED FROM THE ENDOSCOPE AND A THIRD RESOLUTION CLIP WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT COMPLICATIONS. SEVERAL ATTEMPTS TO ASCERTAIN FURTHER DETAILS (INCLUDING PATIENT INFORMATION AND FOLLOW-UP PROCEDURE INFORMATION) HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522610 10070106C2

    Patients

    Seq Age Sex Outcome Treatment
    1