BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1260032 · Received December 9, 2008

    Report

    Report Number
    2182269-2008-00342
    Event Type
    Injury
    Date Received
    December 9, 2008
    Date of Event
    November 17, 2008
    Report Date
    December 9, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED; THEREFORE, AN EVALUATION COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFORMATION PROVIDED TO ST. JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) DISPLAYS A SYMBOL TO ILLUSTRATE A USE BEFORE DATE. THE ANGIO-SEAL PACKAGING LABEL IS PRINTED WITH THIS SYMBOL AND THE DATE DESIGNATED AS THE USE BEFORE DATE. THE DEVICE USED IN THIS EVENT EXCEEDED THE USE BEFORE DATE. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES THE ANGIO-SEAL SHOULD BE KEPT AWAY FROM SUNLIGHT, INCLUDING UV LIGHT. THE ANGIO-SEAL SHOULD BE STORED ONLY AT TEMPERATURES BETWEEN 15 DEGREES CELSIUS AND 25 DEGREES CELSIUS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CASE COORDINATING NURSE THAT FOLLOWING AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE, AN 8F ANGIO-SEAL VIP WAS SELECTED FOR USE. DIFFICULTIES WERE ENCOUNTERED AS THE PHYSICIAN ATTEMPTED TO INSERT THE DEVICE INTO THE PATIENT; LEAVING THE COMPONENT PIECES IN THE PATIENT. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REMOVE THE PIECES AND WAS LATER DISCHARGED FROM THE HOSPITAL. THE NURSE STATED THAT THE HOSPITAL USES A PYXIS UNIT TO STORE THE ANGIO-SEALS AND THAT THIS ANGIO-SEAL HAD A USE BY DATE OF 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VIP MGB ST. JUDE MEDICAL NA 2045146

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention