BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVX-300 EXCIMER LASER SYSTEM

    MDR report key: 2002488 · Received January 28, 2011

    Report

    Report Number
    1721279-2011-00002
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 30, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    LPC
    PMA / PMN Number
    P910001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEFECTIVE SHUTTER ASSEMBLY WAS REPLACED AND THE ENGINEER PERFORMED A COMPLETE SERVICE OF UNIT TO ENSURE IT WAS FUNCTIONING PROPERLY. THE ENGINEER CLOSED AND LOCKED ALL DOORS OF THE HOUSING AND COMPLETED THE CALL.

    Description of Event or Problem · 1

    THIS MEDWATCH FORM CONTAINS SUSPECT DEVICE #2, DIRECTLY RELATED TO THE CASE CAPTURED IN MDR# 1721279-2011-00001BV WHICH CONTAINS SUSPECT DEVICE #1. DURING A LASER LEAD REMOVAL CASE THE PRACTITIONER RECEIVED A FAULT CODE 15. THE LASER SHEATH WAS REMOVED FROM THE PATIENT, CLEANED OFF AND RECALIBRATED. AFTER 10 LASER PULSES ANOTHER FAULT CODE 15 APPEARED. THE SECOND ATTEMPT TO RECALIBRATE TO THE LASER SHEATH RESULTED IN A FAULT CODE 2. IT WAS AT THIS POINT THE PHYSICIAN INSTRUCTED A MEMBER OF HIS TEAM TO RETRIEVE ANOTHER CVX-300 EXCIMER LASER SYSTEM LOCATED IN THE HOSPITAL IN ORDER TO COMPLETE THE LEAD REMOVAL CASE. THE PATIENT'S VITALS REMAINED STABLE DURING THE LASER EXCHANGE BUT RESULTED IN A 1 HOUR DELAY IN PATIENT CARE. A FIELD SERVICE CALL WAS INITIATED ON (B)(6) 2010 AND THE FIELD SERVICE ENGINEER ARRIVED IN SWEDEN ON (B)(6) 2011 TO EVALUATE THE LASER SYSTEM. UPON ARRIVAL THE LASER SYSTEM WORKED PROPERLY. DURING AN EXTENDED CHECK, THE ENGINEER WAS ABLE TO REPRODUCE THE FAULT CODE 15 (DEFINED AS: ELECTRICAL OR ELECTRONIC; REPLACE ELECTRICAL/ELECTRONIC ASSEMBLY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVX-300 EXCIMER LASER SYSTEM CVX-300 LPC SPECTRANETICS CORP. GEN 4.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SLS II (UNKNOWN MODEL/LOT#)