BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACROSS RF WIRE KIT

    MDR report key: 16117816 · Received January 6, 2023

    Report

    Report Number
    3019751610-2023-00006
    Event Type
    Malfunction
    Date Received
    January 6, 2023
    Date of Event
    December 7, 2022
    Report Date
    January 6, 2023
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DSA
    UDI-DI
    00685447011118
    PMA / PMN Number
    K023334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE THERE WAS NO PATIENT INJURY REPORT, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE 20-MINUTE PROCEDURAL DELAY. A DHR REVIEW WAS COMPLETED AND THE DEVICE FULFILLED ALL REQUIREMENTS PRIOR TO RELEASE.

    Description of Event or Problem · 0

    A 20-MINUTE PROCEDURAL WAS REPORTED FOR THE VERSACROSS RF WIRE KIT (CONTAINING THE VERSACROSS RF WIRE AND AN RFP-100A CONNECTOR CABLE (CONNECTOR CABLE)) WHERE THE CONNECTOR CABLE WAS NOT ABLE TO ESTABLISH A CONNECTION WHEN CONNECTED TO THE VERSACROSS RF WIRE AND COMPATIBLE RF GENERATOR DURING A LEFT-ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE. WHILE ATTEMPTING TO COMPLETE THE TRANSSEPTAL PUNCTURE, THE VERSACROSS WIRE WAS POSITIONED ON THE SEPTUM AND WAS THEN CONNECTED TO THE GENERATOR THROUGH THE CONNECTOR CABLE. HOWEVER, THE GENERATOR DID NOT RECOGNIZE THAT THE DEVICE WAS CONNECTED. THE CONNECTOR CABLE WAS DISCONNECTED AND RECONNECTED, HOWEVER, THE GENERATOR STILL DID NOT DETECT THE DEVICE. THE GROUNDING PAD THAT WAS CONNECTED TO THE GENERATOR WAS ALSO SWAPPED OUT AND THE GENERATOR WAS REPLACED WITH A SECOND GENERATOR. HOWEVER, THE ISSUE CONTINUED TO PERSIST. AN NRG TRANSSEPTAL NEEDLE AND CONNECTOR CABLE (BAYLIS MEDICAL COMPANY INC.) WERE OPENED AND CONNECTED TO THE FIRST GENERATOR AND THE TRANSSEPTAL PUNCTURE WAS SUCCESSFULLY COMPLETED. 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
    2301336 VERSACROSS RF WIRE KIT CABLE, TRANSDUCER AND ELECTRODE, PATIENT, INCLUDING CONNECTOR DSA BAYLIS MEDICAL COMPANY INC. VXW-35-230-P-WM VXFB250522 00685447011118

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other