BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACROSS RF WIRE

    MDR report key: 11814363 · Received May 12, 2021

    Report

    Report Number
    9710452-2021-00028
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    April 15, 2021
    Report Date
    May 12, 2021
    Product Code
    DXF
    UDI-DI
    00685447003311
    PMA / PMN Number
    K150709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE 30-MINUTE PROCEDURAL DELAY. DHR REVIEW WAS COMPLETED FOR THE LOT IN QUESTION, AND IT WAS CONFIRMED THAT ALL DEVICES MET RELEVANT REQUIREMENTS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    A 30-MINUTE PROCEDURAL DELAY WAS REPORTED DUE TO THE BUCKLING OF THE VERSACROSS RF WIRE COATING. THE PROCEDURE WAS CONTINUED AFTER USER MANIPULATION TO ALLOW FOR THE VERSACROSS TRANSSEPTAL SHEATH TO BE EXCHANGED OVER THE WIRE. AFTER THE TRANSSEPTAL ACCESS, THE VERSACROSS RF WIRE WAS EXCHANGED FOR A DIFFERENT WIRE FOR THE REMAINING MITRACLIP 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
    708067 VERSACROSS RF WIRE CATHETER, SEPTOSTOMY DXF VXW-35-230-P VXFB100321 00685447003311

    Patients

    Seq Age Sex Outcome Treatment
    1 Other