BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL EVOLUTION

    MDR report key: 1910532 · Received November 19, 2010

    Report

    Report Number
    2182269-2010-00217
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 19, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 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) CAUTIONS, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) STATES THAT IF PATIENTS HAVE CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE, BASED ON PUBLISHED MEDICAL LITERATURE, THE ANGIO-SEAL DEVICE CAN BE DEPLOYED SAFELY IN PATIENT ARTERIES >5 MM DIAMETER WHEN THERE IS FOUND TO BE NO LUMINAL NARROWING OF 40% OR GREATER WITHIN 5 MM OF THE PUNCTURE SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANGIO-SEAL EVOLUTION WAS SELECTED FOR USE. THE PATIENT WAS UNDERGOING A PERIPHERAL PROCEDURE TO TREAT A GI BLEED. REPORTEDLY, THERE WAS PERIPHERAL VASCULAR DISEASE AT THE PUNCTURE SITE AND THE APPROXIMATE DIAMETER OF THE ARTERY WAS 5MM. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED AND THE ANGIO-SEAL WAS DEPLOYED. HEMOSTASIS WAS NOT ACHIEVED AND MANUAL COMPRESSION WAS APPLIED FOR 15 MINUTES. APPROXIMATELY 2 HOURS LATER, THE PATIENT'S LEG WAS FOUND TO BE COLD AND PULSES WERE ABSENT. THE PHYSICIAN SUSPECTED THAT THE RIGHT COMMON FEMORAL ARTERY (RCFA) WAS OCCLUDED AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR A SURGICAL CONSULTATION. THE PATIENT WAS ASSESSED TO BE TOO HIGH RISK FOR SURGICAL ENDARTERECTOMY AND IS BEING GIVEN PALLIATIVE CARE INSTEAD. THE PATIENT REMAINS HOSPITALIZED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R