BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1002559 · Received February 26, 2008

    Report

    Report Number
    2182269-2008-00061
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    February 4, 2008
    Report Date
    February 20, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT BLEEDING OR 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 INSTRUCT THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE. IF NECESSARY, MONITOR PEDAL PULSES. THE IFU INSTRUCTS THE USER ONCE A FULL REAR LOCK POSITION HAS BEEN ACHIEVED, AND THE DEVICE IS BEING DEPLOYED, TO NOT RE-INSERT THE DEVICE. RE-INSERTION OF THE DEVICE AFTER PARTIAL DEPLOYMENT COULD CAUSE COLLAGEN TO BE DEPOSITED IN THE ARTERY. THE IFU ALSO STATE FAILURE TO MAINTAIN TENSION ON THE SUTURE WHILE ADVANCING THE COLLAGEN COULD CAUSE THE COLLAGEN TO ENTER THE ARTERY. THE IFU STATES THAT IF COLLAGEN DEPOSITION INTO THE ARTERY IS SUSPECTED, THE DIAGNOSIS CAN BE CONFIRMED BY DUPLEX ULTRASOUND. TREATMENT OF THIS MAY INCLUDE THROMBOLYSIS, PERCUTANEOUS THROMBECTOMY, OR SURGICAL INTERVENTION. THE IFU CAUTIONS THE USE OF THE ANGIO-SEAL DEVICE IN PATIENTS WITH CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE. THE 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 FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION (PCI) AN 8F ANGIO-SEAL STS PLUS WAS SELECTED FOR USE. NO PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED BECAUSE THE PROCEDURE SHEATH INTRODUCTION INTO THE PATIENT WAS NOT DIFFICULT. DIFFICULTIES WERE ENCOUNTERED DURING DEPLOYMENT AS THE PHYSICIAN TAMPED THE COLLAGEN, ACTIVE BLEEDING OCCURRED. THE BLEEDING STOPPED WHEN THE PHYSICIAN HELD TENSION ON THE SUTURE. WHEN THE TENSION WAS RELEASED, BLEEDING REOCCURRED. THE SUTURE WAS HELD WITH UPWARD TENSION FOR 1 HOUR. HEMOSTASIS WAS NOT ACHIEVED AND MANUAL COMPRESSION WAS REQUIRED TO OBTAIN HEMOSTASIS. THE PATIENT'S DOSALIS PEDIS PULSE WAS PALPABLE AT THE END OF THE PROCEDURE. TWO DAYS LATER, AN ULTRASOUND REVEALED INTRA-ARTERIAL COLLAGEN. THE PATIENT'S ANKLE BRACHIAL INDEX (ABI) WAS 0.60. THE NEXT DAY, THE PATENT UNDERWENT SURGICAL INTERVENTION AND A SYNTHETIC GRAFT REPAIRED THE ARTERY. SEVERE CALCIFICATION WAS PRESENT AT THE STENOSED ARTERIAL SITE OF THE ANGIO-SEAL DEPLOYMENT. THE ANGIO-SEAL WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS 8F ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL NA 2038234

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention