BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACROSS RF WIRE

    MDR report key: 12334121 · Received August 17, 2021

    Report

    Report Number
    9710452-2021-00040
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    July 20, 2021
    Report Date
    August 17, 2021
    Product Code
    DXF
    UDI-DI
    00685447003311
    PMA / PMN Number
    K150709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT IMPACT OR CONSEQUENCE. BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL DELAY THAT OCCURRED. DHR REVIEW WAS COMPLETED FOR THE LOT IN QUESTION AND THE DEVICE FULFILLED ALL REQUIREMENTS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    A 20-MINUTE PROCEDURAL DELAY WAS REPORTED IN A CASE WHERE THE VERSACROSS RF WIRE CAUSED AN ERROR CODE IN THE BAYLIS RADIOFREQUENCY PERFORATION GENERATOR. THE ERROR CODE PERSISTED AFTER USING ANOTHER GENERATOR. THE ISSUE WAS RESOLVED WHEN ANOTHER VERSACROSS RF WIRE WAS USED FOR THE PROCEDURE. WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231981 VERSACROSS RF WIRE CATHETER, SEPTOSTOMY DXF VXW-35-230-P VXFA100521 00685447003311

    Patients

    Seq Age Sex Outcome Treatment
    1 Other