BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 926363 · Received October 12, 2007

    Report

    Report Number
    2182269-2007-00287
    Event Type
    Injury
    Date Received
    October 12, 2007
    Date of Event
    September 5, 2007
    Report Date
    September 26, 2007
    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 FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE LOTS CONFIRMED THESE LOTS MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. LOT 2023048 MANUFACTURING DATE IS 5/2007 AND EXPIRATION DATE IS 5/1/2008. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTION FOR USE (IFU) STATE THAT IF 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 IFU ALSO CAUTIONS THE USE OF THE ANGIO-SEAL DEVICE IN PT'S WITH CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A LEFT COMMON ILIAC PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), A 6F ANGIO-SEAL STS PLUS WAS DEPLOYED AND HEMOSTASIS WAS ACHIEVED. FOLLOWING THAT, A PTA OF THE LEFT SUPERFICIAL FEMORAL ARTERY WAS PERFORMED VIA A LEFT FEMORAL ARTERY ANTEGRADE APPROACH. DURING THE PROCEDURE, A GUIDEWIRE WAS ADVANCED INTO A FALSE CHANNEL AND AN ARTERIAL DISSECTION OCCURRED. THE PTA WAS DISCONTINUED. A 6F ANGIO-SEAL STS PLUS WAS DEPLOYED AND HEMOSTASIS WAS ACHIEVED. MANUAL COMPRESSION WAS APPLIED FOR 20 MINUTES, FOLLOWED BY A SANDBAG TO BLOCK THE DISSECTION. FIVE HOURS LATE, THE PT EXPERIENCED A THROMBOTIC OCCLUSION. THE PHYSICIAN ATTEMPT TO REMOVE THROMBUS VIA A RIGHT COMMON FEMORAL ARTERY APPROACH BUT FAILED. THE PT UNDERWENT SURGERY. THE PHYSICIAN STATED THAT THE EVENT WAS CAUSED BY THROMBOSIS OF THE ARTERIAL DISSECTION AND COMPRESSION OF ARTERY DURING MANUAL COMPRESSION AND THE SANDBAG.

    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 NA 2013480

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention