BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE UNKNOWN

    MDR report key: 1242969 · Received November 20, 2008

    Report

    Report Number
    2182269-2008-00285
    Event Type
    Injury
    Date Received
    November 20, 2008
    Report Date
    November 20, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTIONS THAT A PSEUDOANEURYSM IS A POSSIBLE RISK ASSOCIATED WITH THE USE OF THE ANGIO-SEAL DEVICE OR VASCULAR ACCESS PROCEDURES. IF SUSPECTED, THESE CONDITIONS MAY BE EVALUATED WITH DUPLEX ULTRASOUND. WHEN INDICATED, ULTRASOUND-GUIDED COMPRESSION OF A PSEUDOANEURYSM MAY BE USED AFTER THE ANGIO-SEAL DEVICE HAS BEEN PLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A PRINTED LITERATURE ARTICLE THAT AN ANGIO-SEAL WAS DEPLOYED POST INTERVENTION PROCEDURE, VIA A RETROGRADE PUNCTURE. ULTRASOUND WAS USED TO ASSESS CALCIFICATION. APPROXIMATELY 24 HOURS LATER, A SMALL PSEUDOANEURYSM DEVELOPED; HOWEVER IT DID NOT REQUIRE INTERVENTION. THE IMPLANT AND EVENT DATE ARE UNKNOWN; SOMETIME BETWEEN 2002 AND 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL DEVICE UNKNOWN ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other HEPARIN (2000-9000 UNITS) AT THE TIME OF THE| PROCEDURE.