BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION II CLIP

    MDR report key: 2052201 · Received April 12, 2011

    Report

    Report Number
    3005099803-2011-01202
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Report Date
    March 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K102764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION II CLIP WAS USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WOULD NOT DETACH FROM THE CATHETER AFTER DEPLOYING. THE PHYSICIAN WAS ABLE TO PULL ON THE DELIVERY CATHETER AND SHAKE IT TO RELEASE THE CLIP. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE FINE POST PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, INCLUDING PATIENT AND FOLLOW-UP PROCEDURE INFORMATION, 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 II CLIP HEMORRHOID LIGATOR MND BOSTON SCIENTIFIC - MARLBOROUGH M00522510

    Patients

    Seq Age Sex Outcome Treatment
    1