BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1034064 · Received April 22, 2008

    Report

    Report Number
    2182269-2008-00124
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    February 23, 2008
    Report Date
    March 27, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A REVIEW OF THE LOT HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. 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 THE PT WAS TREATED IN THE CARDIOVASCULAR LAB ON THREE DIFFERENT OCCASIONS. AN ANGIO-SEAL WAS DEPLOYED IN THE RIGHT FEMORAL ARTERIOTOMY FOR THE FIRST PROCEDURE AND ANOTHER ANGIO-SEAL WAS DEPLOYED ONE DAY LATER FOR THE SECOND PROCEDURE. TWO DAYS LATER, THE THIRD PROCEDURE WAS PERFORMED AND THE PROCEDURE SHEATH WAS SUTURED INTO PLACE POST PROCEDURE. THE PT DEVELOPED ACUTE RIGHT LOWER LIMB ISCHEMIA. THE PT WAS REFERRED TO VASCULAR SURGERY FOR REPAIR OF THE ARTERY. THE PT WAS RECOVERING.

    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 NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention