BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1892369 · Received October 27, 2010

    Report

    Report Number
    2182269-2010-00199
    Event Type
    Injury
    Date Received
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVAL AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO PROVIDED TO ST JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTION FOR USE (IFU) STATES, 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 FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A 6F ANGIO-SEAL WAS SELECTED FOR USE IN THE RIGHT COMMON FEMORAL ARTERY. THE PT'S PULSES WERE NOTED TO BE ABSENT VIA DOPPLER AND THE LEG WAS COLD TO TOUCH. A CT ANGIOGRAM (CTA) REVEALED THAT THE PT HAD A THROMBOTIC/EMBOLIC OCCLUSION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE PT WENT TO THE OPERATING ROOM. THE REPORT REVEALED A FRAGMENT OF THE ANGIO-SEAL WAS EXTRACTED FROM THE RIGHT SFA. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R