BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD RX

    MDR report key: 1040378 · Received May 6, 2008

    Report

    Report Number
    1016427-2008-00136
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Date of Event
    June 15, 2007
    Report Date
    April 14, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PREP OF THE ANGIOGUARD, THE PHYSICIAN TOOK THE DEVICE OUT OF THE PACKAGE AND SAW AN EXTRA CLEAR PLASTIC PIECE BY THE DEVICE. THERE DID NOT SEEM TO BE ANYTHING MISSING FROM THE DEVICE, BUT THE PHYSICIAN WANTED TO BE CAUTIOUS AND OPENED A SECOND DEVICE. THE FIRST DEVICE WAS NEVER USED IN THE PT. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVAL, LAKE REGION MEDICAL IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO MFG, INSPECTING AND PACKAGING. THIS PACKAGING LOT CONTAINED UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON NOV 22, 2006. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. WITH THE LIMITED AMOUNT OF INFO AVAILABLE, AND WITHOUT THE RETURN OF THE PRODUCT FOR ANALYSIS, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT.

    Description of Event or Problem · 1

    DURING PREPPING, THE PHYSICIAN TOOK OUT AN ANGIOGUARD RX OUT OF PACKAGE AND HE SAW AN EXTRA CLEAR PLASTIC PIECE BY THE DEVICE. THERE DID NOT SEEM TO BE ANYTHING MISSING FROM THE DEVICE, BUT THE PHYSICIAN WANTED TO BE CAUTIOUS AND OPENED A SECOND DEVICE. THE FIRST DEVICE WAS NEVER USED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 71106506

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR