BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS-X

    MDR report key: 3769620 · Received April 1, 2014

    Report

    Report Number
    1318694-2014-00002
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Date of Event
    October 11, 2013
    Report Date
    March 31, 2014
    Manufacturer
    NUMED, INC.
    Product Code
    OZT
    PMA / PMN Number
    K082776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT ENOUGH INFO WAS PROVIDED BY THE DISTRIBUTOR AND USER FACILITY. IT IS UNK AS TO WHAT RBP THE CATHETER BURST AT AND IT IS ALSO UNKNOWN WHETHER OR NOT AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED AS IS RECOMMENDED IN THE INSTRUCTION FOR USE. THE COMPARATIVE CATHETER THAT WAS PULLED FROM INVENTORY WAS TESTED FOR RBP. THE LABELED RBP OF THIS DEVICE IS 3.0 ATM. THE COMPARATIVE CATHETER DID NOT BURST UNTIL 6.0 ATM OF PRESSURE. DUE TO THE LACK OF INFO, NUMED IS UNABLE TO DETERMINE WAS CAUSED THIS BALLOON BURST.

    Description of Event or Problem · 1

    THE BALLOON BURST DURING AN AORTIC VALVULOPLASTY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196103 NUCLEUS-X BALLOON AORTIC VALVULOPLASTY CATHETER OZT NUMED, INC. 230X NX-0306

    Patients

    Seq Age Sex Outcome Treatment
    1