BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES

    MDR report key: 1904524 · Received November 22, 2010

    Report

    Report Number
    3005099803-2010-04803
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Report Date
    November 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2010 THAT A SENSATION OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE WOULD NOT DELIVER CURRENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA M00562672

    Patients

    Seq Age Sex Outcome Treatment
    1