BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1689409 · Received May 11, 2010

    Report

    Report Number
    2182269-2010-00098
    Event Type
    Injury
    Date Received
    May 11, 2010
    Date of Event
    October 1, 2009
    Report Date
    May 11, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. THE EXACT LOT NUMBER WAS UNAVAILABLE, HOWEVER; THE REVIEW OF THE HISTORY FOR TWO POSSIBLE LOTS PROVIDED 2791392 AND 2795420 CONFIRMED THAT THEY MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFORMATION PROVIDED TO ST JUDE MEDICAL, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTION THAT A PSEUDOANEURYSM IS A POSSIBLE RISK ASSOCIATED WITH THE USE OF THE ANGIO-SEAL DEVICE OR VASCULAR ACCESS PROCEDURES. IF SUSPECTED, THESE CONDITIONS MAY BE EVALUATED WITH DUPLEX ULTRASOUND. WHEN INDICATED, ULTRASOUND-GUIDED COMPRESSION OF A PSEUDOANEURYSM MAY BE USED AFTER THE ANGIO-SEAL DEVICE HAS BEEN PLACED. THE ANGIO-SEAL DEVICE IFU STATES THE 6F ANGIO-SEAL DEVICE SHOULD BE USED ON 6F OR SMALLER PROCEDURE SHEATH ARTERIOTOMIES AND THE 8F ANGIO-SEAL SHOULD BE USED ON 8F OR SMALLER PROCEDURE SHEATH ARTERIOTOMIES.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A CAROTID ARTERY STENTING (CAS), AN ANGIO-SEAL STS PLUS WAS SELECTED FOR USE. IT WAS UNKNOWN IF A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED OR NOT. THE PUNCTURED ARTERY WAS REPORTEDLY A COMMON FEMORAL ARTERY (CFA) PUNCTURE WITH NO CALCIFICATION. A 9F SHEATH WAS ALSO USED DURING THE PROCEDURE. AFTER THE 9F SHEATH WAS EXCHANGED FOR AN 8F SHEATH, THE PHYSICIAN WAITED APPROXIMATELY FIVE MINUTES TO DEPLOY THE ANGIO-SEAL AND HEMOSTASIS WAS IMMEDIATELY ACHIEVED. TWO DAYS AFTER DEPLOYMENT, A PULSATILE MASS, PAIN, AND VASCULAR BRUIT WERE NOTED. A CT ANGIOGRAPHY REVEALED A 4 CM PSEUDOANEURYSM AROUND THE PUNCTURE SITE. THE PSEUDOANEURYSM WAS COMPRESSED WITH ULTRASOUND GUIDANCE THREE TIMES FOR 10 MINUTE INTERVALS AND HEMOSTASIS WAS UNABLE TO BE RE-ACHIEVED. MANUAL COMPRESSION WAS ALSO APPLIED APPROXIMATELY SIX TIMES FOR TEN MINUTE INTERVALS AND REPAIR OF THE PSEUDOANEURYSM WAS FINALLY CONFIRMED. FIVE DAYS LATER, A CT ANGIOGRAPHY REVEALED IMPROVED BLOOD FLOW. THE PATIENT WAS TAKING PRESCRIBED MEDICATIONS (DOSE UNKNOWN) HEPARIN AND ASPIRIN. THE COMPLAINT PRODUCT WAS EITHER FROM LOT 2791392 OR 2795420. THE EVENT DATE WAS MONTH SPECIFIC OCCURRING SOMETIME IN (B) (6) 2009. ADDITIONAL INFORMATION WAS NOT AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R