BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENACURE 65CM FIBER

    MDR report key: 922029 · Received October 1, 2007

    Report

    Report Number
    1319211-2007-00032
    Event Type
    Malfunction
    Date Received
    October 1, 2007
    Date of Event
    August 31, 2007
    Report Date
    September 25, 2007
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY RECORD REVIEW: THE LOT NUMBER WAS NOT REPORTED. A SHIP HISTORY WAS CONDUCTED ON THE REPORTED PART NUMBER. THE SHIP HISTORY SHOWED THE FOLLOWING LOTS HAD BEEN SHIPPED TO THE COMPLAINANT IN THE LAST 9 MONTHS: 919027, 919666, 933529, 934951 AND 935882. THE LOT HISTORY RECORDS FOR THE ABOVE LISTED POSSIBLE NUMBERS WERE REVIEWED FOR ANY ABNORMALITIES WHICH, MAY HAVE CONTRIBUTED TO THE CAUSE OF THE COMPLAINT. NOTHING KNOWN TO HAVE CONTRIBUTED TO THE COMPLAINT WAS OBSERVED. REVIEW OF RETURNED SAMPLE: THE COMPLAINT SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. CONCLUSION: THE COMPLAINT INVESTIGATION IS INCONCLUSIVE. THE COMPLAINT SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. THE CAUSE OF THE COMPLAINT IS UNKNOWN. IT IS POSSIBLE THE SHEATH MELTED DUE TO THE FIBER BREAK AND THAT THE CAUSE OF THE FIBER BREAK IS IMPROPER HANDLING. ALL FIBERS ARE 100% INSPECTED AND TESTED BEFORE RELEASE. THIS TYPE OF COMPLAINT WOULD HAVE BEEN NOTICED DURING THE ANGIODYNAMICS MANUFACTURING OR PACKAGING PROCESS. THE FOLLOWING STATEMENT IS CONTAINED IN THE INSTRUCTIONS FOR USE TO HELP AVOID THIS TYPE OF COMPLAINT FROM HAPPENING: PRECAUTION: PRIOR TO AND DURING USE, AVOID DAMAGING THE FIBER BY STRIKING, STRESSING, OR EXCESSIVE BENDING OF THE FIBER. DO NOT COIL THE FIBER TIGHTER THAN A DIAMETER OF 20CM. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION AT THIS TIME. FREQUENCY HAS INCREASED BUT THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL.

    Description of Event or Problem · 1

    LASER FIBER BURNED THROUGH SHEATH AND BROKE OFF - APPROX 3CM OF BOTH FIBER AND TIP REMAIN IN THE PATIENT. FOLLOW UP U/S PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENACURE 65CM FIBER ENDOVASCULAR LASER VENOUS SYSTEM GEX ANGIODYNAMICS, INC. NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 YR