BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTOSNARE

    MDR report key: 2111746 · Received June 2, 2011

    Report

    Report Number
    3005099803-2011-01836
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FDI
    PMA / PMN Number
    K992477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-01837 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ROTATABLE OVAL SNARES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, WITH AMPULLECTOMY, PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, IT WAS DIFFICULT TO EXTEND AND RETRACT THE LOOP OF THE FIRST SNARE ONCE IT HAD BEEN ADVANCED THROUGH THE SCOPE ELEVATOR. THE SAME ISSUE THEN OCCURED WITH THE SECOND SNARE, AND THE PROCEDURE WAS COMPLETED WITH A CAPTIVATOR 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 ROTOSNARE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA M00561831 0014167076

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR