BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS

    MDR report key: 1213263 · Received October 24, 2008

    Report

    Report Number
    2182269-2008-00237
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    February 2, 2005
    Report Date
    October 24, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P93038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTIONS SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AROUND EARLY 2005, A PT RECEIVED AN ANGIO-SEAL STS FOLLOWING A PERCUTANEOUS INTERVENTIONAL PROCEDURE. TWO DAYS FOLLOWING THE PROCEDURE, THE PT DEVELOPED COMPLICATIONS. THE PT UNDERWENT A LEG AMPUTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS 6F ANGIO-SEAL STS DEVICE MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R