BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVX-300 EXCIMER LASER SYSTEM

    MDR report key: 1961654 · Received December 27, 2010

    Report

    Report Number
    1721279-2010-00083
    Event Type
    Malfunction
    Date Received
    December 27, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    PMA / PMN Number
    P910001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER INVESTIGATION SUMMARY: (B)(4). ON ARRIVAL, STARTED SYSTEM NORMALLY AND ATTEMPTED TO CALIBRATE REFERENCE CATHETER. CALIBRATION FAILED WITH A FC4 THREE TIMES IN A ROW. STARTED SERVICE CALL AND FOUND THAT ENERGY WAS LOW AND FPM WAS OUT OF SPECIFICATION. ALIGNED LASER AND FOUND THAT ENERGY INCREASED BY 19MJ. OBSERVED THAT COVER BUMPERS HAVE SCRATCHES AND ABRASIONS ON ALL SIDES. INSPECTED BEAM ATTENUATOR AND COULD NOT FIND ANY LOOSE HARDWARE, ENSURED THAT SETSCREWS WERE TIGHT. COMPLETED CALIBRATION (B)(4) WITHOUT ANY FURTHER PROBLEMS. SALES REP COMPLAINED THAT FOOTSWITCH CONNECTOR HAD TO BE ROCKED SOMETIMES TO CLEAR FOOTSWITCH FAULT LIGHT ON CONTROL PANEL. CONFIRMED PROBLEM. REPLACED FOOTSWITCH AND FOOTSWITCH CONNECTOR. FOOTSWITCH OPERATION IS NOW RELIABLE. STAYED TO OBSERVE A LEAD EXTRACTION CASE IN ITS ENTIRETY. THIS CASE REQUIRED THE USE OF TWO DIFFERENT LASER SHEATHS WITH THE RESULTING REQUIREMENTS FOR MULTIPLE CALIBRATIONS DURING PROCEDURE. SYSTEM PERFORMED FLAWLESSLY. ROOT CAUSES: PROBLEM: FC4. CAUSE: FPM OUT OF SPECIFICATION. SOLUTION: ALIGNED LASER AND CALIBRATED FPM. PROBLEM: FOOTSWITCH ERROR. CAUSE: MATING PROBLEM BETWEEN FOOTSWITCH PLUG AND RECEPTACLE. SOLUTION: REPLACED FOOTSWITCH AND RECEPTACLE (CONNECTOR ASSEMBLY). RECOMMENDED TO CUSTOMER TO ENSURE PROPER CARE WHILE TRANSPORTING SYSTEM.

    Description of Event or Problem · 1

    THIS WAS TO BE A LEFT-SIDED, CARDIAC LEAD REMOVAL PROCEDURE CONDUCTED IN THE CARDIAC CATHETER LAB. THE INDICATION WAS TO REMOVE A FRACTURED RV LEAD, WITH AN OCCLUDED SUBCLAVIAN VEIN, FOR UPGRADE TO CRTD FROM ICD. THE MD TRIED TO CALIBRATE THE REFERENCE CATHETER AND RECEIVED A FC (FAULT CODE) 2 AND A FC4. HE THEN ATTEMPTED TO CALIBRATE THE 14F SLS AND RECEIVED ANOTHER FC4. THE TIP OF THE CATHETER AND DETECTOR WERE CLEANED BUT THE MD STILL RECEIVED A FC4. THE SPNC REPRESENTATIVE WAS PRESENT AND CALLED THE FIELD SERVICE DEPARTMENT FOR ASSISTANCE. UNFORTUNATELY, THE PROBLEM COULD NOT BE FIXED OVER THE PHONE. IT WAS AT THIS TIME, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE HOSPITAL. THE ARRIVAL OF THE FSE WAS NOT POSSIBLE UNTIL THE NEXT MORNING ((B)(6) 2010). THE PATIENT HAD ALREADY BEEN PREPPED AT THIS POINT WITH THE POCKET OPEN AND LEADS READY FOR EXTRACTION. THE MD SECURED AND CLOSED THE POCKET AND SENT THE PATIENT BACK TO INPATIENT STATUS. THE PATIENT WAS BROUGHT BACK TO THE CARDIAC CATHETER LAB ON (B)(6) 2010, AFTER THE FSE HAD SUCCESSFULLY RETURNED THE LASER TO A FUNCTIONAL STATUS. THE CASE WAS COMPLETED WITH NO DEVICE OR PATIENT COMPLICATIONS. THE PATIENT RECOVERED AND WAS DISCHARGED TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVX-300 EXCIMER LASER SYSTEM CVX-300 MFA SPECTRANETICS CORP. CVX-300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization LLD#1 (518-018)| 14F SLS (500-012)