BEUDAMED
    FDA Adverse Event Death Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1012522 · Received March 11, 2008

    Report

    Report Number
    3003681312-2008-00021
    Event Type
    Death
    Date Received
    March 11, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANGIO-SEAL USED WAS FROM ONE OF THREE LOTS; 2043413, 2042397, OR 2042408. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THESE LOTS MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. #2043413 MFR DATE 11/2007, EXP DATE 11/1/2008. #2042397 MFG DATE 10/2007, EXP DATE 10/1/2008. #2042408 MFG DATE 10/2007, EXP DATE 10/1/2008. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE PHYSICIAN STATED THE PATIENT'S CLINICAL CONDITION WAS THE CAUSE, NOT THE ANGIO-SEAL. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATE THAT BLEEDING OR HEMATOMA AT THE PUNCTURE SITE IS A POSSIBLE RISK OR SITUATION THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE OR VASCULAR ACCESS PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCT THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE. IF NECESSARY, MONITOR PEDAL PULSES. THE ANGIO-SEAL DEVICE IFU STATES THE SAFETY AND EFFECTIVENESS OF THE ANGIO-SEAL DEVICE HAS NOT BEEN ESTABLISHED IN PATIENTS WITH A BLEEDING DISORDER.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A DIAGNOSTIC HEART CATHETERIZATION PROCEDURE THAT A 6F ANGIO-SEAL VIP WAS DEPLOYED WITH GOOD HEMOSTASIS. TWENTY HOURS LATER, THE PATIENT EXPERIENCED BLEEDING AT THE GROIN SITE A LARGE HEMATOMA DEVELOPED. A FEMOSTOP WAS APPLIED TO THE GROIN AND HEMOSTASIS WAS ACHIEVED. WITHIN MINUTES OF OBTAINING HEMOSTASIS THE PATIENT BLED AGAIN AND MANUAL COMPRESSION ACHIEVED HEMOSTASIS. THE PHYSICIAN STATED THE PATIENT DEVELOPED DISSEMINATED INTRAVASCULAR COAGULATION (DIC) AND DIED. THE PHYSICIAN STATED THE PATIENT WAS VERY ILL AND NOTHING WAS WRONG WITH THE ANGIO-SEAL. THE ANGIO-SEAL USED WAS FROM ONE OF THREE LOTS; 2043413, 22042397, OR 2042408.

    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 PUERTO RICO, B.V. NA 2042413

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| O| R