BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARSTASIS ACCESS SYSTEM

    MDR report key: 1960258 · Received January 6, 2011

    Report

    Report Number
    3008493244-2011-00001
    Event Type
    Other
    Date Received
    January 6, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    ARSTASIS INC.
    Product Code
    DYB
    PMA / PMN Number
    K102728
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE DID NOT MALFUNCTION AND WAS NOT RETURNED FOR INVESTIGATION. FIELD REPORTS INDICATE THAT THE PT HAD HIGHLY CALCIFIED DISEASED ARTERY AT THE ACCESS SITE AND THIS MAY HAVE CONTRIBUTED TO THE FORMATION OF THE HEMATOMA.

    Description of Event or Problem · 1

    PHYSICIAN PERFORMED AN "ARSTAOTOMY" ON A FEMALE PT WITH HIGHLY CALCIFIED ARTERY AT THE ACCESS SITE. FOLLOWING THE PROCEDURE, WHILE HOLDING MANUAL COMPRESSION, THE PT DEVELOPED A 15 CM HEMATOMA BELOW THE PUNCTURE SITE ON THE THIGH. HEMATOMA WAS TREATED WITH COMPRESSION. PT WAS KEPT OVERNIGHT FOR OBSERVATION AND DISCHARGED THE FOLLOWING DAY WITHOUT FURTHER SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARSTASIS ACCESS SYSTEM INTRODUCER CATHETER DYB ARSTASIS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R