BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE

    MDR report key: 1062924 · Received June 11, 2008

    Report

    Report Number
    2182269-2008-00158
    Event Type
    Injury
    Date Received
    June 11, 2008
    Date of Event
    October 14, 2004
    Report Date
    May 21, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    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 EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTIONS 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 INSTRUCTIONS FOR USE (IFU) STATE POTENTIAL ADVERSE REACTIONS OR CONDITIONS MAY BE ASSOCIATED WITH ONE OR MORE ANGIO-SEAL DEVICE COMPONENTS (IE, COLLAGEN, SYNTHETIC ABSORBABLE SUTURE, AND/OR POLYMER). THESE INCLUDE ALLERGIC REACTION, FOREIGN BODY REACTION, POTENTIATION OF INFECTION, INFLAMMATION AND EDEMA. 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 BY THE PT FOLLOWING AN ANGIOGRAM PROCEDURE, AN ANGIO-SEAL WAS USED. THE PT REPORTED WHEN AMBULATING, THE PT'S LEG DRAGGED WHILE WALKING. THE PT WAS DISCHARGED. FOUR DAYS LATER, THE PT CONTACTED THE PHYSICIANS' OFFICE BECAUSE THEIR LEG CONDITION WAS UNCHANGED. AN ULTRASOUND WAS PERFORMED AND REVEALED AN ANEURYSM IN THE RIGHT FEMORAL ARTERY. THE PT WAS ADMITTED AND UNDERWENT SURGICAL INTERVENTION 2 DAYS LATER. THE ARTERY WAS REPAIRED AND A GRAFT WAS INSERTED. THE PT STATED THAT THE RIGHT LEG AND FOOT ISSUE CONTINUED AND BECAME WORSE. THE PT SOUGHT ANOTHER OPINION AND REPORTED THAT SHE UNDERWENT SUBSEQUENT SURGERIES TO TREAT BLOOD CLOTS AND HAD MULTIPLE GRAFT REPLACEMENTS. THE PT REPORTED THAT ANKLE BRACHIAL INDEX STUDIES DOCUMENTED NO BLOOD FLOW IN THE INCISION AREA DOWN THE LEG WHEN THE PT STANDS OR WALKS. THE RIGHT GROIN AND THIGH AREA REMAINS NUMB. THE PT STATES THAT THE PHYSICIANS REPORT THE DISABLED LEG WILL NOT IMPROVE AND MAY REQUIRE AMPUTATION IN THE FUTURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention THE PT'S MEDICATIONS ARE PLAVIX 75 MG| COUMADIN, 15 MG| ASPIRIN, 81 MG AND| OTHER UNK MEDICATIONS