BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1062727 · Received June 17, 2008

    Report

    Report Number
    3003681312-2008-00066
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    March 19, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO. B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTION, 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 AN ANGIO-DEAL WAS DEPLOYED IN THE RIGHT FEMORAL ARTERIOTOMY POST CAROTID ANGIOGRAPHY. THIRTY MINS AFTER RETURNING TO RECOVERY, THE PT LOST DISTAL PULSES. THE PT WENT TO SURGERY FOR REMOVAL OF THE ANGIO-SEAL FROM THE COMMON FEMORAL ARTERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AND THE PT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VIP MGB ST. JUDE MEDICAL PUERTO RICO. B.V. NA 2051869

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention