BEUDAMED
    FDA Adverse Event Death Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1062565 · Received June 17, 2008

    Report

    Report Number
    2182269-2008-00154
    Event Type
    Death
    Date Received
    June 17, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROD WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO REC'D, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. 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 (I.E. COLLAGEN, SYNTHETIC ABSORBABLE SUTURE, AND/OR POLYMER). THESE INCLUDE ALLERGIC REACTION, FOREIGN BODY REACTION, POTENTIATION OF INFECTION, INFLAMMATION AND EDEMA. THE ANGIO-SEAL INSTRUCTION FOR USE (IFU) STATE THAT IF COLLAGEN DEPOSITION INTO THE ARTERY OR THROMBOSIS AT THE PUNCTURE SITE IS SUSPECTED, THE DIAGNOSIS CAN BE CONFIRMED BY DUPLEX ULTRASOUND. TREATMENT OF THIS MAY INCLUDE THROMBOLYSIS, PERCUTANEOUS THROMBECTOMY, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTION 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) PRECAUTION THE USE OF THE ANGIO-SEAL DEVICE IN PTS WITH CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT THE ANGIO-SEAL KIT IS SUPPLIED STERILE IN A POLY BAG. THE BAG INCLUDES A SEALED TRAY CONTAINING THE ANGIO-SEAL COMPONENTS. THE ANGIO-SEAL IS LABELED STERILE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANGIO-SEAL WAS DEPLOYED IN THE RIGHT COMMON FEMORAL ARTERIOTOMY (RCFA) POST CARDIAC CATHETERIZATION. THE PHYSICIAN FIRST ATTEMPTED TO CLOSE THE ARTERIOTOMY WITH A PERCLOSE DEVICE. HEMOSTASIS WAS NOT ACHIEVED AND THE PHYSICIAN THEN USED THE ANGIO-SEAL. THE NEXT DAY, THE PT'S FOOT BECAME COLD. THE PT WENT TO SURGERY AND HAD A CUT DOWN PROCEDURE IN THE RCFA TO REMOVE COLLAGEN IN THE ARTERY. AFTERWARDS, THE PT DEVELOPED AN INFECTION AT THE PUNCTURE SITE. THERE WAS A TWO DAY DELAY IN GETTING THE PT BACK INTO SURGERY. THE PT BLED FROM THE GROIN AND DIED. THE PHYSICIAN ADMITTED THAT HE USED THE ANGIO-SEAL OFF LABEL BECAUSE THE PT HAD SEVERE ATHEROSCLEROSIS.

    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 93 YR Death| O| R