BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1884065 · Received October 20, 2010

    Report

    Report Number
    2182269-2010-00191
    Event Type
    Injury
    Date Received
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE PHYSICIAN STATED THAT THE PT'S ARTERY WAS LESS THAN 4 MM IN DIAMETER. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) PRECAUTION THE USE OF THE ANGIO-SEAL IN PEDIATRIC PTS OR OTHERS WITH SMALL FEMORAL ARTERY SIZE (<4 MM IN DIAMETER). SMALL FEMORAL ARTERY SIZE MAY PREVENT THE ANGIO-SEAL ANCHOR FROM DEPLOYING PROPERLY IN THESE PTS. THE IFU ALSO STATES 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 A 6F ANGIO-SEAL VIP WAS DEPLOYED IN THE COMMON FEMORAL ARTERY (CFA) WITHOUT ANY DIFFICULTIES. THE PHYSICIAN STATED THAT THE ARTERY WAS SMALLER THAN 4 MM. AFTER ONE HOUR, THE PT COMPLAINED OF LEG PAIN AND SYMPTOMS OF VESSEL OCCLUSION. THE PT UNDERWENT SURGICAL INTERVENTION WHERE IT WAS DIAGNOSED THAT THE VESSEL OCCLUSION WAS AT THE SITE OF ANGIO-SEAL PLACEMENT. THE PT WAS REPORTED TO BE FINE FOLLOWING SURGERY. THE PHYSICIAN STATED THE EVENT WAS CAUSED BY PLACING THE ANGIO-SEAL IN A VESSEL DIAMETER SMALLER THAN 4 MM. THE EVENT DATE, IMPLANT DATE, EXPLANT DATE, AND LOT NUMBER WERE UNK.

    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 UNK Hospitalization| R