BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL EVOLUTION

    MDR report key: 2100807 · Received May 19, 2011

    Report

    Report Number
    2182269-2011-00081
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    March 19, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO 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 INSTRUCTION FOR USE (IFU) STATES THAT BLEEDING OR A HEMATOMA AT THE PUNCTURE SITE IS A POSSIBLE RISK OR SITUATION THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE OR VASCULAR ACCESS PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCTS THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE AND IF NECESSARY, MONITOR PEDAL PULSES. THE ANGIO-SEAL DEVICE IFU INSTRUCTS THE USER NOT TO USE THE ANGIO-SEAL DEVICE IF THE PUNCTURE SITE IS PROXIMAL TO THE INGUINAL LIGAMENT AS THIS MAY RESULT IN A RETROPERITONEAL BLEED. THE ANGIO-SEAL DEVICE IFU STATES THAT A SINGLE WALL PUNCTURE TECHNIQUE SHOULD BE USED. THE POSTERIOR WALL OF THE ARTERY SHOULD NOT BE PUNCTURED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 6F ANGIO-SEAL EVOLUTION WAS SELECTED FOR CLOSURE OF THE LEFT FEMORAL ARTERIOTOMY FOLLOWING A LEFT HEART CATHETERIZATION. FOLLOWING THE PROCEDURE, TRIPLE ANTIBIOTIC OINTMENT WAS APPLIED OVER THE PUNCTURE SITE AND TRANSPARENT DRESSING WAS APPLIED OVER STERILE 4X4. ON (B)(6) 2011, FOUR DAYS FOLLOWING THE ANGIO-SEAL DEPLOYMENT, THE PT RETURNED TO THE EMERGENCY ROOM (ER) WITH SYNCOPE. UPON FURTHER EXAMINATION AND A COMPUTED TOMOGRAPHY (CT) SCAN, THE ER PHYSICIAN CONCLUDED THAT THE PT HAD AN ACUTE PSEUDOANEURYSM IN THE LEFT EXTERNAL ILIAC ARTERY AND ACUTE INTRA-ABDOMINAL/PELVIC BLEEDING. SURGERY WAS PERFORMED ON THE LEFT ILIAC ARTERY. THE PT WAS REPORTEDLY DISCHARGED AND STABLE FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL EVOLUTION ANGIO-SEAL EVOLUTION MGB ST. JUDE MEDICAL NA 3210036

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R