BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C2 CRYOBALLOON FOCAL CONTROLLER

    MDR report key: 6252041 · Received January 13, 2017

    Report

    Report Number
    3008780134-2017-00002
    Event Type
    Malfunction
    Date Received
    January 13, 2017
    Date of Event
    December 20, 2016
    Report Date
    January 13, 2017
    Manufacturer
    C2 THERAPEUTICS, INC.
    Product Code
    GEH
    PMA / PMN Number
    K161202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTROLLER CAP WAS RETURNED WITH A CIRCULAR HOLE IN THE TOP, AND TWO FRAGMENTS WERE ALSO RETURNED. THE CAP WAS VISUALLY AND DIMENSIONALLY INSPECTED, AND NO ABNORMALITIES WERE OBSERVED. THE FUNCTIONALITY OF THE BROKEN CAP WAS EVALUATED BY INSERTING AN UNUSED CARTRIDGE INTO THE CONTROLLER CAP AND TIGHTENING THE CONTROLLER CAP ONTO THE CONTROLLER IN THE SAME MANNER DESCRIBED IN THE INSTRUCTIONS FOR USE. THE CARTRIDGE AND CONTROLLER CAP WERE SUCCESSFULLY ASSEMBLED. THE CONTROLLER SUCCESSFULLY COMPLETED AN ABLATION CYCLE. ADDITIONAL EVALUATIONS USING MAXIMUM MANUAL FORCE POSSIBLE DURING WORST CASE USE WERE USED TO TIGHTEN AN UNUSED CARTRIDGE AND UNUSED CONTROLLER CAP INTO THE CONTROLLER, BUT THE FRACTURE COULD NOT BE REPLICATED. A TEST WAS DEVELOPED TO MECHANICALLY INDUCE EXTREME FORCE APPLIED TO THE TOP OF THE CAP TO CAUSE FAILURE, AND A SIMILAR FRACTURE WAS OBSERVED. GIVEN THAT THE EXTREME ARTIFICIAL FORCE REQUIRED TO REPLICATE THE FRACTURE IS NOT POSSIBLE CLINICALLY, THE SPECIFIC CAUSE OF THE FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING DEVICE PREPARATION, AS THE NITROUS OXIDE CARTRIDGE WAS BEING LOADED INTO THE CONTROLLER, THE CARTRIDGE MOVED, CAUSING THE TOP OF THE CONTROLLER CAP TO FRAGMENT AND SEPARATE. ONE OF THE FRAGMENTS STRUCK THE TECHNICIAN'S FINGER, CAUSING MINOR, TEMPORARY DISCOMFORT THAT HAD RESOLVED THE FOLLOWING DAY. THE TECHNICIAN STATED THAT SHE MAY NOT HAVE LOADED THE CARTRIDGE CORRECTLY INTO THE CONTROLLER CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33035 C2 CRYOBALLOON FOCAL CONTROLLER CRYOSURGICAL UNIT AND ACCESSORIES GEH C2 THERAPEUTICS, INC. FG-1012 10212016-01

    Patients

    Seq Age Sex Outcome Treatment
    1