BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1160480 · Received September 12, 2008

    Report

    Report Number
    2182269-2008-00203
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    August 9, 2008
    Report Date
    September 12, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO RECEIVED, THE CAUSE FOR THE REPORTED EVENT 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 PT INFO GUIDE STATE SOME BRUISING OR DISCOMFORT IS COMMON DURING THE HEALING PROCESS AFTER INTRAVASCULAR PROCEDURES; HOWEVER, THE PT SHOULD CONTACT THEIR PHYSICIAN IMMEDIATELY AT THE NUMBER LISTED ON THE PT INFO CARD IF THEY EXPERIENCE FEVER, BLEEDING, PERSISTENT SWELLING 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 FOLLOWING A DIAGNOSTIC HEART CATHETERIZATION A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE. AFTER A FEMORAL ANGIOGRAM WAS PERFORMED, THE ANGIO-SEAL WAS DEPLOYED. THE PT WAS DISCHARGED. NINE DAYS LATER THE PT RETURNED TO THE EMERGENCY ROOM (ER) WITH RIGHT GROIN PAIN AND SOME LIGHT OOZING OF BLOOD. THE ER PHYSICIAN NOTED A 2 TO 3 CENTIMETER (CM) PULSATILE MASS AT THE RIGHT GROIN WITH NO HEMATOMA PRESENT. AN ULTRASOUND REVEALED A 3 CM PSEUDOANEURYSM. THE PT WAS TREATED WITH A THROMBIN INJECTION, DOSE UNK, AND WAS SENT HOME THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VIP MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R LOVENOX| PRESCRIBED ANTI-COAGULANT MEDICATION