BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 2190962 · Received July 28, 2011

    Report

    Report Number
    3003681312-2011-00055
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO PROVIDED TO ST JUDE MEDICAL, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. 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 PROCEDURES. 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. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) INSTRUCTS THE USER TO ASSESS THE PUNCTURE SITE LOCATION AND EVALUATE THE FEMORAL ARTERY CHARACTERISTICS PRIOR TO PLACING THE ANGIO-SEAL DEVICE BY INJECTING CONTRAST MEDIUM THROUGH THE PROCEDURE SHEATH AND USING FLUOROSCOPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANGIO-SEAL DEVICE WAS USED FOLLOWING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WITH A STENT IMPLANTATION FOR STENOSIS DISEASE IN THE RIGHT CORONARY ARTERY VIA A RIGHT FEMORAL ARTERY PUNCTURE. TWO HOURS AFTER THE PROCEDURE, A HEMATOMA HAD FORMED AT THE PUNCTURE SITE. MANUAL COMPRESSION WAS APPLIED TO CONTROL THE BLEEDING. THE PT'S HEMOGLOBIN WAS ALSO NOTED TO HAVE DROPPED FOUR POINTS AND THE PT ALSO REPORTED SOME WEAKNESS / FAINTING FEELING. A PLASMA EXPANDER WAS ADMINISTERED AND THE PT WAS REPORTED TO BE FINE. THE PT'S HOSPITALIZATION WAS EXTENDED DUE TO THIS EVENT, BUT WAS LATER DISCHARGED WITH NO FURTHER ISSUES BEING NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL PUERTO RICO, B.V. NA 3344268

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R HEPARIN (5000 UNITS)| CLOPIDOGREL (75 MG)| ASPIRIN (700 MG)