BEUDAMED
    FDA Adverse Event Death Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE

    MDR report key: 1644694 · Received March 26, 2010

    Report

    Report Number
    2182269-2010-00053
    Event Type
    Death
    Date Received
    March 26, 2010
    Report Date
    March 26, 2010
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    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 PT'S INFORMATION GUIDE, WHICH THE PT IS INSTRUCTED TO CARRY WITH THEM FOR 90 DAYS STATES SOME BRUISING OR DISCOMFORT IS COMMON DURING THE HEALING PROCESS AFTER INTRAVASCULAR PROCEDURE; HOWEVER, IF ANY OF THE FOLLOWING SYMPTOMS ARE EXPERIENCED THE PT IS TO CONTACT THEIR PHYSICIAN IMMEDIATELY AT THE NUMBER LISTED ON THEIR PT 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. 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 PROCEDURE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED A PT HAD A PERIPHERAL INTERVENTION PROCEDURE PERFORMED. THE RIGHT GROIN WAS SEALED WITH A 6F ANGIO-SEAL STS PLUS. THE PT WENT TO THE FLOOR FOR RECOVERY AND AMBULATED THAT EVENING WITH NO PROBLEMS. THE FOLLOWING DAY THE PT WAS IN THE PROCESS OF BEING DISCHARGED FROM THE HOSPITAL AND THE PT FAINTED. THE PT WAS TAKEN TO SURGERY TO HAVE THE RIGHT FEMORAL ARTERY REPAIRED. AT SOME POINT DURING THE SURGERY, THE PT WAS INTUBATED. THE PT EXPIRED AT SOME POINT AFTER BEING INTUBATED. THE TIME AND DATE OF THE PT DEATH ARE UNK. ADDITIONAL INFORMATION WAS NOT AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death| H| R