BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SNARE

    MDR report key: 3922817 · Received July 9, 2014

    Report

    Report Number
    3005099803-2014-02520
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K992477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL SNARE WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AN ERROR MESSAGE WAS OBSERVED ON THE GENERATOR. WHEN THE SNARE WAS REPLACED WITH ANOTHER OF THE SAME TYPE, THERE WAS NO ERROR MESSAGE DISPLAYED SO IT WAS SUSPECTED THAT THE ORIGINAL SNARE HAD MALFUNCTIONED. IT WAS REPORTED THAT THERE WAS NO VISIBLE DAMAGE TO THE DEVICE. THE PROCEDURE WAS COMPLETED WITH THE SECOND ROTATABLE 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400519 ROTATABLE SNARE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00561831

    Patients

    Seq Age Sex Outcome Treatment
    1