BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUALASE COOLING LASER APPLICATOR SYSTEM

    MDR report key: 10471849 · Received August 31, 2020

    Report

    Report Number
    1045254-2020-00387
    Event Type
    Malfunction
    Date Received
    August 31, 2020
    Date of Event
    July 27, 2020
    Report Date
    August 31, 2020
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GEX
    UDI-DI
    00643169933378
    PMA / PMN Number
    K053087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT, WHILE TESTING WITH THE THERMAL THERAPY SYSTEM, THERE WAS AN ISSUE WITH THE DISPOSABLE COOLING CATHETER SYSTEM (CCS) KIT. IT WAS REPORTED THAT LESIONS FORMED NON-UNIFORMLY AND ABLATED TISSUE WAS ONE SIDED AS THE UNIT ABLATED IN A 180 DEGREE REGION INSTEAD OF 360 DEGREES AROUND THE LASER DIFFUSING FIBER (LDF). IT WAS REPORTED THAT TISSUE TESTING WAS BEING CONDUCTED WHERE UNDER SMALLER ABLATION TIMES, THE ABLATED TISSUE WAS ON ONE SIDE OF THE LDF AND CATHETER. IT WAS NOTED THAT SWITCHING LDF'S DID NOT RESTORE FUNCTIONALITY, LEADING TO THE COOLING CATHETER BEING SUSPECTED TO BE THE CAUSE OF THE ISSUE. IT WAS NOTED THAT A 15W LASER WITH 8ML/MIN FLOW AND 16 SECONDS OF EXPOSURE TIME WERE BEING USED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935890 VISUALASE COOLING LASER APPLICATOR SYSTEM LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC XOMED INC. 9735561 0217005544 00643169933378

    Patients

    Seq Age Sex Outcome Treatment
    1