BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2914908 · Received January 9, 2013

    Report

    Report Number
    3003681312-2012-00083
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 12, 2012
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO- SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES IF PATIENTS HAVE CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE, BASED ON PUBLISHED MEDICAL LITERATURE, THE ANGIO-SEAL DEVICE CAN BE DEPLOYED SAFELY IN PATIENT ARTERIES >5 MM DIAMETER WHEN THERE IS FOUND TO BE NO LUMINAL NARROWING OF 40% OR GREATER WITHIN 5 MM OF THE PUNCTURE SITE.

    Description of Event or Problem · 1

    A 6F ANGIO-SEAL VIP WAS DEPLOYED FOLLOWING A PRE-DEPLOYMENT ANGIOGRAM, WHICH DETERMINED THAT THE VESSEL WAS SUITABLE FOR ANGIO-SEAL USE. IT APPEARED THAT HEMOSTASIS WAS ACHIEVED, BUT THEN THE SITE BEGAN TO BLEED AND THE PT THEN LOST PEDAL PULSES. ULTRASOUND CONFIRMED THE ANGIO-SEAL WAS DEPLOYED INTRA-ARTERIALLY. IT IS UNKNOWN IF THERE WAS A DISEASE AT THE PUNCTURE SITE OR IF THE PUNCTURE WAS ON OR AT THE BIFURCATION. THE PATIENT WAS STABLE AND WAS SCHEDULED FOR A STENT PLACEMENT TO RESTORE BLOOD FLOW. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12012 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 3793538

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R