BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUALASE COOLED LASER APPLICATION SYSTEM

    MDR report key: 3966153 · Received June 26, 2014

    Report

    Report Number
    3005726841-2014-00005
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BIOTEX
    Product Code
    GEX
    PMA / PMN Number
    053087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS A COOLING CATHETER SYSTEM (CCS). IT IS A DEVICE THAT IS USED WITH THE LASER DIFFUSING FIBER (LDF). BOTH THESE DEVICES ARE SOLD AS A SYSTEM KNOWN AS VISUALASE COOLING LASER APPLICATOR SYSTEM (VCLAS). THE CCS IS USED TO PROVIDE INFUSION OF STERILE SALINE AROUND THE LDF WHILE SIMULTANEOUSLY REMOVING THAT FROM TISSUE ADJACENT TO ITS OUTER WALL. THE SALINE THAT LEAKED FROM THE CCS INTO THE PATIENT IS A STERILE SOLUTION USED ROUTINELY FOR INFUSION AND IRRIGATION DURING SURGERY. THE SUSPECT DEVICE WAS RETURNED. IT HAS BEEN DETERMINED THAT DURING MANUFACTURING OF THE SUSPECT CCS, THE DEVICE WAS NOT ASSEMBLED CORRECTLY WHICH CAUSED THE INTERIOR LUMEN TO BE 3MM SHORT. PRIOR TO PLACEMENT OF THE DEVICE, A STIFFENING STYLET (AN ACCESSORY THAT STIFFENS THE TUBE FOR INSERTION INTO THE BODY) WAS INSERTED INTO THE CCS AND PUSHED THROUGH THE TIP OF THE CCS. THE TIP OF THE CCS WOULD HAVE BROKEN OFF PRIOR TO CCS PLACEMENT IN THE BODY. WITHOUT THE TIP BEING PRESENT THE SALINE LEAKED FROM THE CCS. (B)(4). NO OTHER COMPLAINTS OF TIPS BREAKING HAVE BEEN REPORTED. POST PROCEDURE, THE DOCTOR REPORTED TO THE DISTRIBUTOR THAT THE PATIENT WAS "DOING FINE" AND SEIZURE FREE.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED THAT UPON TURNING ON THE SALINE PUMP AT THE BEGINNING OF THE ABLATION, AN ARTIFACT WAS SEEN IN THE SCAN. THE PUMP WAS TURNED OFF AND THE ARTIFACT WAS DETERMINED TO BE THE SALINE. THE PROCEDURE WAS EXTENDED APPROXIMATELY 2 HOURS WHILE THE COOLING CATHETER SYSTEM (CCS) WAS REMOVED AND A NEW CCS AND LASER DIFFUSING FIBER (LDF) WERE USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372911 VISUALASE COOLED LASER APPLICATION SYSTEM VCLAS GEX BIOTEX VCLAS 400-12-T10-11 132196-05

    Patients

    Seq Age Sex Outcome Treatment
    1