BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 2251216 · Received September 12, 2011

    Report

    Report Number
    2182269-2011-00143
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 19, 2011
    Report Date
    September 9, 2011
    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. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG 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 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 INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE USER NOT TO USE THE ANGIO-SEAL DEVICE IF THE PUNCTURE SITE IS PROXIMAL TO THE INGUINAL LIGAMENT AS THIS MAY RESULT IN A RETROPERITONEAL BLEED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES THAT A SINGLE WALL PUNCTURE TECHNIQUE SHOULD BE USED. THE POSTERIOR WALL OF THE ARTERY SHOULD NOT BE PUNCTURED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES THAT THE SAFETY AND EFFECTIVENESS OF THE ANGIO-SEAL DEVICE HAS NOT BEEN ESTABLISHED FOR PTS UNDERGOING AN INTERVENTIONAL PROCEDURE WHOM ARE BEING TREATED WITH WARFARIN.

    Description of Event or Problem · 1

    FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH STENT PLACEMENT IN THE RIGHT COMMON ARTERY PROXIMAL LESION VIA A RIGHT FEMORAL ARTERY APPROACH, A 8F ANGIO-SEAL STS PLUS WAS SELECTED FOR USE. A PRE-DEPLOYMENT ANGIOGRAM REVEALED A COMMON FEMORAL ARTERY (CFA) WITH MILD CALCIFICATION. THE ARTERY LUMEN DIAMETER WAS 7.0MM. THE ANGIO-SEAL SEEMED TO BE DEPLOYED WITHOUT A PROBLEM. THE PT WAS TRANSFERRED FROM THE CATHETERIZATION LAB TO THE WARD. ABOUT HALF AN HOUR AFTER THE ANGIO-SEAL DEPLOYMENT, THE PT COMPLAINED OF PAIN IN HER GROIN AND THEN WENT INTO SHOCK. MASSIVE QUANTITIES OF BLOOD FLOWED INTO RETROPERITONEAL SPACE. THE AMOUNT OF HEMOGLOBIN IN THE BLOOD DROPPED FROM 11.7G/DL TO 5G/DL. MANUAL COMPRESSION WAS APPLIED FOR 2-3 HOURS, BUT HEMOSTASIS WAS NOT ACHIEVED. THE PT WAS TRANSFERRED TO THE OPERATING ROOM WITH THE BLEEDING SITE DILATED WITH A BALLOON CATHETER AND RECEIVED A BLOOD TRANSFUSION. THE TOTAL AMOUNT OF BLOOD USED WAS 3,000 ML. THE SURGICAL OPERATION WAS PERFORMED AND HEMOSTASIS WAS ACHIEVED. THE OPERATIVE FINDINGS REVEALED THAT THE PUNCTURE SITE WAS LOCATED IN THE UPPER INGUINAL LIGAMENT, AND THE MUSCULAR TISSUE OF THE LIGAMENT PREVENT CLOSE BETWEEN THE ANCHOR AND THE COLLAGEN. THE PT RECOVERED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL NA 3374575

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R PLAVIX (75 MG/DAY)| ASPIRIN (200 MG/DAY)| WARFARIN (2MG/DAY)| AND HEPARIN 5500 UNITS DURING THE PCI.| BEFORE THE PCI