BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACROSS RF WIRE

    MDR report key: 16118767 · Received January 6, 2023

    Report

    Report Number
    3019751610-2023-00005
    Event Type
    Malfunction
    Date Received
    January 6, 2023
    Date of Event
    October 3, 2022
    Report Date
    January 6, 2023
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DXF
    UDI-DI
    00685447003298
    PMA / PMN Number
    K150709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INCIDENT WAS FOUND ON THE FDA MAUDE DATABASE BY BAYLIS MEDICAL COMPANY INC. THE INCIDENT WAS INITALLY REPORTED TO FDA BY A USER FACILITY; HOWEVER, THE USER FACILITY IS UNKNOWN AND THERE WAS NO FURTHER INFORMATION PROVIDED TO BAYLIS MEDICAL COMPANY INC. A DHR REVIEW WAS COMPLETED FOR ALL THE DEVICES IN THE LOT AND ALL DEVICES MET RELEVANT SPECIFICATIONS PRIOR TO RELEASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, THE VERSACROSS RF WIRE USED DURING TRANSSEPTAL SHEARED OFF. THERE IS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635450 VERSACROSS RF WIRE CATHETER, SEPTOSTOMY DXF BAYLIS MEDICAL COMPANY INC. VXW-35-180-P VXFC060422 00685447003298

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other