BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUALASE GUIDED ABLATION SYSTEM

    MDR report key: 8143016 · Received December 7, 2018

    Report

    Report Number
    1723170-2018-06130
    Event Type
    Malfunction
    Date Received
    December 7, 2018
    Date of Event
    November 30, 2018
    Report Date
    January 4, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    UDI-DI
    00643169655935
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER FIELD NOT SUFFICIENT TO HOLD ALL DIGITS, SHOULD READ: ME - (B)(6). NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION: FDD UPDATED TO PROPER VALUE. THE LASER DIFFUSING FIBER (LDF) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. TESTING FOUND THAT THE LUER OF THE UNIT WAS DAMAGED AS THE THREADING ON THE SCREW WAS WORN OR MISSING AND THAT IT WOULD NOT LOCK ONTO THE CATHETER. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT, WHILE IN A SOFT NEURO TISSUE ABLATION, THE CLEAR CAP OF THE LASER DIFFUSING FIBER (LDF) COULD NOT BE FULLY SECURED TO THE COOLING CATHETER SYSTEM (CCS). IT WAS NOTED THAT THE CAP WOULD ROTATE CONTINUOUSLY. A SECOND KIT WAS OPENED AND THE LDF COULD BE ATTACHED TO THE CCS. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN FIVE MINUTES DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981596 VISUALASE GUIDED ABLATION SYSTEM LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC NAVIGATION, INC 9735542 00643169655935

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR