BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRANETICS EXCIMER LASER SYSTEM

    MDR report key: 4211931 · Received October 29, 2014

    Report

    Report Number
    1721279-2014-00192
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    LPC
    PMA / PMN Number
    P910001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXCIMER LASER EVALUATION (PERFORMED AT THE FACILITY): UPON ARRIVAL, FSE CONFIRMED FAULT CODE 04 DURING CALIBRATION. FOUND HVPS LOW AND REGULATED ENERY LOW. ADJUSTED HVPS AND MONITORS. SYSTEM STABLE AFTER 10 MINUTE RUN. COMPLETED CAL FORM. SYSTEM FUNCTIONING TO SPECIFICATION.

    Description of Event or Problem · 1

    THIS WAS A LEAD EXTRACTION CASE PERFORMED IN THE HYBRID OR TO REMOVE TWO NON-FUNCTIONING LEADS FROM THE RA (MDT 5568 AND 5076, IMPLANTED FOR 89 MONTHS). THE FIRST LEAD (MDT 5568) WAS SUCCESSFULLY EXTRACTED WITH NO ISSUES. THE SECOND LEAD (MDT 5076) WAS PREPPED WITH AN LLD-EZ AND A LASER CATHETER WAS USED FOR THE EXTRACTION. DURING THE PROCEDURE, THE LASER GAVE A FAULT CODE, AND STOPPED WORKING. THE MANUFACTURER ENGINEER WAS CALLED AND INSTRUCTIONS WERE PROVIDED TO TRY AND RESET THE LASER. AFTER TRYING ALL POSSIBLE REMEDIES, AND THE LASER NOT FUNCTIONING, THE PHYSICIAN DETERMINED THE BEST METHOD TO TREAT THE PATIENT WAS TO LEAVE THE REMAINING LEAD IN PLACE. THERE WERE NO ALTERNATIVE MEANS AVAILABLE FOR THIS PHYSICIAN TO EXTRACT THE LEAD. THE PATIENT HAD AN OCCLUDED SVC AND THE PHYSICIAN WAS UNABLE TO PUT IN A NEW RA LEAD. THE PHYSICIAN CUT AND CAPPED THE 5076 LEAD, LEAVING A PART OF THE LLD IN THE LEAD IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692938 SPECTRANETICS EXCIMER LASER SYSTEM CVX-300 EXCIMER LASER LPC SPECTRANETICS CORPORATION CVX-300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other LEAD LOCKING DEVICE| VISISHEATH DILATOR SHEATH| GLIDELIGHT LASER SHEATH