BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE EVOLUTION

    MDR report key: 2116752 · Received May 26, 2011

    Report

    Report Number
    2182269-2011-00096
    Event Type
    Injury
    Date Received
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. 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 PROCEDURE. 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A META-ANALYSIS LITERATURE ARTICLE, "ANGIO-SEAL EVOLUTION VERSUS MANUAL COMPRESSION FOR COMMON FEMORAL ARTERY PUNCTURE IN NEUROVASCULAR DIAGNOSTIC ANGIOGRAPHY," IN J KOREAN NEUROSURGERY JOURNAL VOLUME 49(3): 153-5, ISSUED MARCH 2011, WRITTEN BY DR. CHUNG J. LEE, DR. OS KWON, DR. BS KIM, DR. YS KIM. FROM (B)(6) 2009, 169 DIAGNOSTIC TRANS-FEMORAL CEREBRAL ANGIOGRAPHIES WERE PERFORMED, USING EITHER ANGIO-SEAL EVOLUTION OR MANUAL COMPRESSION TO ACHIEVE HEMOSTASIS. SIXTY PATIENTS WERE INCLUDED IN THIS STUDY, 30 IN EACH GROUP. MINOR COMPLICATIONS AS THOSE REQUIRING NO FURTHER TREATMENT SUCH AS A HEMATOMA SIZE LESS THAN 6 CM AND BRUISE SIZE LESS THAN 25 CM. MAJOR COMPLICATIONS WERE THOSE REQUIRING SURGERY OF THE FEMORAL ARTERY PSEUDOANEURYSM AND/OR THE SECOND LINE INCREASE OF HOSPITAL STAY EVEN WITHOUT FURTHER TREATMENT. MEAN TIME TO HEMOSTASIS WAS 0.42+/-0.04 MINUTES FOR THE ANGIO-SEAL AND 15.83+/-1.63 MINUTES FOR MANUAL COMPRESSION (P<0.001). OVERALL COMPLICATION RATE DID NOT DIFFER BETWEEN THE 2 GROUPS. AFTER THE PATIENTS WERE FULLY MOBILE, AT 24 HOURS, THE RATE OF ONSET OF NEW COMPLICATION DIFFERED SIGNIFICANTLY BETWEEN THE 2 GROUPS (P=0.032). IN THE ANGIO-SEAL GROUP, 5 (16.7%) OF THE 30 PATIENTS EXPERIENCED THE ONSET OF A NEW COMPLICATION AFTER 24 HOURS, INCLUDING 3 (60%) OF THE 5 WHO EXPERIENCED MAJOR COMPLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R