BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK ANGIOGUARD

    MDR report key: 1083779 · Received July 24, 2008

    Report

    Report Number
    1016427-2008-00204
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    May 27, 2008
    Report Date
    July 10, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVAL. THE LOT NUMBER IS NOT KNOWN; THEREFORE, A DEVICE HISTORY REVIEW IS NOT POSSIBLE. WITH THE LIMITED AVAILABLE PROCEDURAL INFO AND WITHOUT THE RETURN OF THE PRODUCT, NO CONCLUSION CAN BE MADE REGARDING THE REPORTED ANGIOGUARD CAPTURE DIFFICULTY.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED CAPTURING DIFFICULTIES OF THE EMBOLIC PROTECTION DEVICE. THE ANGIOGUARD FILTER BASKET (UNK PRODUCT CODE/LOT#) WAS DEPLOYED TO AN UNK ARTERIAL SITE. ATTEMPTS TO RETRIEVE THE ANGIOGUARD WERE MADE WITH THE CAPTURING SHEATH. HOWEVER, THE SHEATH WAS NOT ABLE TO CAPTURE THE FILTER, THEREFORE, THE FILTER WAS REMOVED WITH A "DAVIS 125 CATHETER". UPON REMOVAL THERE WAS NO DEBRIS OBSERVED IN THE FILTER. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT. NO ADDITIONAL INFO WAS AVAILABLE IN RESPONSE TO REQUEST FOR VESSEL/LESION CHARACTERISTICS, PT DEMOGRAPHICS AND PROCEDURAL INFO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK