BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1201472 · Received October 16, 2008

    Report

    Report Number
    3003681312-2008-00105
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    August 28, 2008
    Report Date
    October 16, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING 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 INSTRUCTION FOR USE (IFU) STATES THAT IF COLLAGEN DEPOSITION INTO THE ARTERY OR THROMBOSIS AT THE PUNCTURE SITE IS SUSPECTED THE DIAGNOSIS CAN BE CONFIRMED BY DUPLEX ULTRASOUND. TREATMENT OF THIS MAY INCLUDE THROMBOLYSIS. PERCUTANEOUS THROMBECTOMY, OR SURGICAL INTERVENTION. THE ANGIO-SEAL INSTRUCTION FOR USE (IFU) WARNS THAT FAILURE TO MAINTAIN TENSION ON THE SUTURE WHILE ADVANCING THE COLLAGEN COULD CAUSE THE COLLAGEN TO ENTER THE ARTERY. ALSO ERRATIC VIGOROUS TAMPING OR EXCESSIVE UPWARD STENSION ON THE SUTURE MAY RESULT IN COLLAGEN PLACEMENT IN THE ARTERY OR ANCHOR BREAKAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 6F ANGIO-SEAL WAS SELECTED FOR USE. THE VESSEL WAS FREE OF STENOSIS AND CALCIFICATION. REPORTEDLY THE ANCHOR BECAME STUCK IN THE COMMON FEMORAL ARTERY DURING DEPLOYMENT AND IT WAS DIFFICULT TO PULL BACK THE DEVICE. THE PHYSICIAN PULLED THE DEVICE BACK VERY STRONGLY; HOWEVER, HEMOSTASIS WAS NOT ACHIEVED. THE PT WENT TO SURGERY WHERE THE ANCHOR AND COLLAGEN WERE REMOVED FROM THE ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS 6F ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 2076371

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention