BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2161792 · Received July 7, 2011

    Report

    Report Number
    3003681312-2011-00051
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 15, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    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 PROVIDED TO ST. JUDE MEDICAL, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN 8F ANGIO-SEAL VIP WAS SELECTED FOR CLOSURE OF A RIGHT COMMON FEMORAL ARTERY PUNCTURE. BEFORE MOVING THE PT TO THE WARD, THE PHYSICIAN EVALUATED THE PT AND NOTICED A SMALL LEAK AT THE PUNCTURE SITE. THE NURSE USED SAND BAGS TO APPLY PRESSURE AND OBTAIN HEMOSTASIS. THE FOLLOWING DAY, THE PT DEVELOPED A HEMATOMA. SURGERY WAS PERFORMED AND THE HEMATOMA WAS RESOLVED. THE ANGIO-SEAL WAS NOT EXPLANTED. THE PT WAS DISCHARGED AFTER A TEN DAY STAY IN THE HOSPITAL AND IS REPORTEDLY STABLE. THE PT RECEIVED PLAVIX (75 MG), 6 TAPS HEPARIN (5,000 U) AND CLOPIDOGREL (600 MG).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 3163189

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R