BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE

    MDR report key: 1150501 · Received September 4, 2008

    Report

    Report Number
    2182269-2008-00204
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    August 6, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 INSTRUCTIONS FOR USE (IFU) CAUTION THAT AN AV FISTULA OR PSEUDOANEURYSM ARE POSSIBLE RISKS OR SITUATIONS 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 PATIENT'S INFORMATION GUIDE, WHICH THE PATIENT IS INSTRUCTED TO CARRY WITH THEM FOR 90 DAYS STATE; SOME BRUISING OR DISCOMFORT IS COMMON DURING THE HEALING PROCESS AFTER INTRAVASCULAR PROCEDURES; HOWEVER, IF ANY OF THE FOLLOWING SYMPTOMS ARE EXPERIENCED THE PATIENT IS TO CONTACT THEIR PHYSICIAN IMMEDIATELY AT THE NUMBER LISTED ON THE PATIENT INFORMATION CARD; FEVER, BLEEDING, PERSISTENT TENDERNESS IN THE GROIN OR SWELLING, REDNESS AND/OR WARM TO TOUCH, NUMBNESS, TINGLING OR PAIN IN THE EXTREMITY WHEN AMBULATING, RASH, WOUND DRAINAGE, OR ANY OTHER UNUSUAL SYMPTOMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANGIO-SEAL WAS DEPLOYED POST CARDIAC CATHETERIZATION. TWO DAYS LATER, WHILE DRIVING THE CAR, THE PATIENT EXPERIENCED PRESSURE IN THE GROIN AND IT BEGAN TO BLEED. PRESSURE WAS HELD ON THE GROIN AND THE BLEEDING STOPPED. THE PATIENT CALLED THE PHYSICIAN'S OFFICE AND AN ULTRASOUND WAS PERFORMED. THE ULTRASOUND WAS NEGATIVE AND THE PATIENT WAS TOLD TO TAKE IT EASY. ONE WEEK LATER THE PATIENT WENT TO THE PHYSICIAN AND ANOTHER ULTRASOUND WAS PERFORMED WHICH REVEALED A BLOOD CLOT. THE PATIENT WAS ADMITTED FOR HEPARIN AND COUMADIN THERAPY (DOSE UNKNOWN). A VASCULAR SURGEON SAW THE PATIENT WHILE HE WAS IN THE HOSPITAL AND ANOTHER ULTRASOUND WAS ORDERED. THAT ULTRASOUND DID NOT SHOW ANY BLOOD CLOTS AND THE HEPARIN AND COUMADIN WERE STOPPED; HOWEVER, A PSEUDOANEURYSM WAS CONFIRMED. THE PATIENT WAS TO RETURN TO THE VASCULAR SURGEON ONE WEEK LATER TO CHECK THE STATUS OF THE PSEUDOANEURYSM. FURTHER TREATMENT HAS NOT BEEN DETERMINED.

    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 66 YR Required Intervention