BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL EVOLUTION DEVICE

    MDR report key: 2051148 · Received April 6, 2011

    Report

    Report Number
    2182269-2011-00059
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    February 18, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE ANGIO-SEAL WAS BEING PULLED BACK THERE, NO RESISTANCE WAS FELT. HEMOSTASIS WAS NOT ACHIEVED AND A FEMOSTOP WAS PLACED ON THE PUNCTURE SITE. THE PHYSICIAN ALLEGED THAT IT APPEARED THERE WAS NO ANCHOR IN THE DEVICE BECAUSE IT COULD NOT BE INITIALLY LOCATED IN THE PATIENT. SOMETIME AFTER DEPLOYMENT, THE PATIENT EXPERIENCED LEG PAIN AND A COLD LEG WITH NO PEDAL PULSES. THE PATIENT UNDERWENT SURGERY (DATE UNKNOWN), WHERE THE ANCHOR WAS LOCATED AND REMOVED. THE PATIENT WAS TAKING PRESCRIBED ANTICOAGULANTS (TYPE AND DOSAGES UNKNOWN). ADDITIONAL INFORMATION WAS NOT AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R THE PATIENT WAS TAKING PRESCRIBED ANTICOAGULANTS| (TYPE AND DOSAGE UNKNOWN)