BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE

    MDR report key: 2620809 · Received June 8, 2012

    Report

    Report Number
    2182269-2012-00058
    Event Type
    Injury
    Date Received
    June 8, 2012
    Report Date
    May 21, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE MEAN AGE OF THE PATIENTS AT THE TIME OF THE EVENT WAS (B)(6). ADDITIONAL INFORMATION: APPROXIMATELY 67% OF THE PATIENTS WERE MALE. 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 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 INSTRUCTIONS FOR USE (IFU) CAUTIONS THE USER TO OBSERVE STERILE TECHNIQUE AT ALL TIMES WHEN USING THE DEVICE. THE USE OF THE DEVICE WHERE BACTERIAL CONTAMINATION OF THE PROCEDURE SHEATH OR SURROUNDING TISSUES MAY HAVE OCCURRED MAY CAUSE INFECTION. ANY SIGN OF INFECTION AT THE PUNCTURE SITE SHOULD BE TAKEN SERIOUSLY AND THE PATIENT MONITORED CAREFULLY. SURGICAL REMOVAL OF THE DEVICE SHOULD BE CONSIDERED WHENEVER AN ACCESS SITE INFECTION IS SUSPECTED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTIONS, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. 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

    THE FOLLOWING INCIDENT WERE REPORTED VIA A LITERATURE ARTICLE "DIFFERENT SPECTRUM OF VASCULAR COMPLICATIONS AFTER ANGIO-SEAL DEPLOYMENT OF MANUAL COMPRESSION" PUBLISHED MARCH 2012 IN THE JOURNAL OF INVASIVE CARDIOLOGY. THE STUDY COMPARED COMPLICATION RATES AFTER ANGIO-SEAL DEPLOYMENT OR MANUAL COMPRESSION. FROM MAY 2007 TO DECEMBER 2007, 672 PATIENTS WERE TREATED WITH MANUAL COMPRESSION. FROM JANUARY 2008 TO MAY 2010, 677 PATIENTS WERE TREATED WITH ANGIO-SEAL STS PLUS AND 604 PATIENTS WERE TREATED WITH ANGIO-SEAL EVOLUTION. VASCULAR COMPLICATIONS WERE OBSERVED IN 55 PATIENTS TREATED WITH ANGIO-SEAL. THE VASCULAR COMPLICATIONS INCLUDED 36 GROIN HEMATOMAS, 1 GROIN INFECTION, 4 PSEUDOANEURYSMS, 1 DISSECTION/THROMBOSIS, 23 RETROPERITONEAL BLEEDS, 28 CASES WHERE A TRANSFUSION WAS NEEDED, 4 CASES THAT REQUIRED SURGICAL REPAIR, 4 IN-HOSPITAL ACUTE MYOCARDIAL INFARCTIONS, AND 10 IN-HOSPITAL DEATHS. MANY OF THESE INCIDENTS WERE ALREADY REPORTED IN ANOTHER LITERATURE ARTICLE BY THE SAME AUTHORS. THE EVENTS WERE INVESTIGATED AND REPORTED TO THE FDA VIA MEDWATCH 2182269-2012-00030, HOWEVER 24 PATIENTS TREATED WITH ANGIO-SEAL STS PLUS WERE NOT INCLUDED IN THE PREVIOUS ARTICLE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE ABOUT SPECIFIC INCIDENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R