BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT-VU HALO

    MDR report key: 950096 · Received November 16, 2007

    Report

    Report Number
    1319211-2007-00037
    Event Type
    Malfunction
    Date Received
    November 16, 2007
    Date of Event
    September 7, 2007
    Report Date
    November 15, 2007
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY RECORD REVIEW: THE LOT NUMBER PROVIDED DOES NOT MATCH ANY LOT NUMBER IN OUR SYSTEM. A SHIP HISTORY WAS CONDUCTED AND SHOWED THE FOLLOWING THREE ORDERS CONSISTING OF 6 LOTS HAD BEEN SHIPPED TO THE COMPLAINANT: ON 09/12/2006 LOT 914199, ON 07/03/2007 LOTS 916425, 918189, 919290 AND 921200 AND ON 09/18/2007 LOT 936233. THE LOT HISTORIES OF THE POSSIBLE LOTS WERE REVIEWED FOR ANY ABNORMALITIES, WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT. NOTHING FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. REVIEW OF RETURNED SAMPLE: THE COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION AND THE FOLLOWING WAS OBSERVED: THE CATHETER WAS RETURNED IN ONE PIECE. THE STRAIGHTENER IS ON THE CATHETER 27CM FROM THE HUB. THE GUIDEWIRE WAS NOT RETURNED FOR EVALUATION. THE SOFT TIP ON THE END OF THE CATHETER IS 1.2CM IN LENGTH. SPECIFICATION IS 6CM +/-.001". THE HOLE AT .5CM IS STRETCHED. THE DISTAL TIP IS STRETCHED AND HAS A FANNED APPEARANCE. CONCLUSION: THE COMPLAINT INVESTIGATION HAS BEEN CONFIRMED DURING THE VISUAL INSPECTION OF THE RETURNED SAMPLE. THE SOFT TIP SECTION OF THE RETURNED SAMPLE IS 1.2CM IN LENGTH, SPECIFICATION IS 6CM +/- .001". THE DRILL HOLE ON THE SOFT TIP IS STRETCHED AND THE DISTAL TIP HAS A FANNED APPEARANCE. THE BREAK IN THE CATHETER TIP APPEARS TO HAVE BEEN CAUSED BY THE GUIDEWIRE GETTING CAUGHT ON THE DRILL HOLE, MEETING RESISTANCE AND STRETCHING THE CATHETER TIP TO THE BREAKING POINT. A REVIEW OF THE MFG RECORDS FOR THE REPORTED LOT INDICATED THAT ALL OF THE DEVICE SPEC AND QUALITY REQUIREMENTS WERE SATISFIED. THIS TYPE OF COMPLAINT WILL 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

    THE PHYSICIAN INSERTED THE CATHETER OVER A GUIDEWIRE. HE FELT A RESISTANCE. WHEN HE TRIED TO WITHDRAW THE CATHETER HE FELT STRONGER RESISTANCE. THE CATHETER TIP WAS STRETCHED AND FINALLY SHEARED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT-VU HALO ANGIOGRAPHIC CATHETER DQO ANGIODYNAMICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other