BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2830124 · Received November 13, 2012

    Report

    Report Number
    3005099803-2012-05369
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    September 14, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION FOUND THAT THE DEVICE RETURNED FULLY DEPLOYED. THE CLIP ASSEMBLY WAS NOT RECEIVED FOR ANALYSIS. ADDITIONALLY, THE CONTROL WIRE, WHICH RETURNED KINKED, WAS SEPARATED AS PER DESIGN. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE CLIP ASSEMBLY WAS DIFFICULT TO RELEASE FROM THE DELIVERY CATHETER. THE EVALUATION REVEALED THAT THE DEVICE RETURNED FULLY DEPLOYED WITH THE CLIP ASSEMBLY SEPARATED FROM THE 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. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF CLIP DIFFICULT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE CLIP HAD DIFFICULTY RELEASING FROM THE CATHETER. AFTER MANIPULATION OF THE DEVICE, THE CLIP SEPARATED FROM THE CATHETER, AND WAS RETRIEVED BY THE PHYSICIAN. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTION CLIP DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE CLIP HAD DIFFICULTY RELEASING FROM THE CATHETER. AFTER MANIPULATION OF THE DEVICE, THE CLIP SEPARATED FROM THE CATHETER, AND WAS RETRIEVED BY THE PHYSICIAN. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTION CLIP DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522612 ML000308C3

    Patients

    Seq Age Sex Outcome Treatment
    1