BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1892355 · Received October 27, 2010

    Report

    Report Number
    2182269-2010-00196
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 INSTRUCTIONS FOR USE (IFU) CAUTIONS THE USE OF THE ANGIO-SEAL DEVICE IN PTS WITH CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2010, A PT HAD A PERIPHERAL PERCUTANEOUS INTERVENTION (PPI) PROCEDURE WITH STENT PLACEMENT IN THE SUPERFICIAL FEMORAL (SFA) VIA A RIGHT FEMORAL ARTERY PUNCTURE USING A CROSSOVER TECHNIQUE AND AN 8F ANGIO-SEAL STS PLUS WAS SELECTED FOR CLOSURE. IT WAS REPORTED THAT A PRE-DEPLOYMENT ANGIOGRAM REVEALED A COMMON FEMORAL ARTERY (CFA) PUNCTURE WITH A 5.0MM LUMEN DIAMETER. ON (B)(6) 2010, AS THE PT WAS GOING TO BE DISCHARGED FROM THE HOSPITAL, THE PT EXPERIENCED RE-BLEEDING AT THE PUNCTURE SITE. MANUAL COMPRESSION WAS APPLIED FOR 15 MINUTES AND HEMOSTASIS WAS ACHIEVED. THE PT WAS KEPT IN THE HOSPITAL FOR ANOTHER DAY FOR FURTHER MONITORING. THE NEXT DAY, THE PT WAS DISCHARGED FROM THE HOSPITAL WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL NA 3102048

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R