BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1232170 · Received November 14, 2008

    Report

    Report Number
    3003681312-2008-00113
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    July 2, 2008
    Report Date
    November 13, 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
    IN, US
    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 OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) STATES 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 CAUTIONS SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL PATIENT INFORMATION GUIDE STATES SOME BRUISING OR DISCOMFORT IS COMMON DURING THE HEALING PROCESS AFTER INTRAVASCULAR PROCEDURES; HOWEVER, THE PATIENT SHOULD CONTACT THEIR PHYSICIAN IMMEDIATELY AT THE NUMBER LISTED ON THE PATIENT INFORMATION CARD IF THEY EXPERIENCE FEVER, BLEEDING, PERSISTENT SWELLING IN THE GROIN OR SWELLING, REDNESS AND/OR WARM TO TOUCH, NUMBNESS, TINGLING OR PAIN IN THE EXTREMITY WHEN AMBULATING, RASH, WOUND DRAINAGE OR ANY OTHER UNUSUAL SYMPTOMS.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A PERCUTANEOUS HEART CATHETERIZATION, AN ANGIO-SEAL VIP WAS PLACED IN THE RIGHT FEMORAL ARTERIOTOMY. A PRE-INSERTION FEMORAL ANGIOGRAM WAS PERFORMED. LATER THAT NIGHT AND INTO THE NEXT DAY, THE PATIENT EXPERIENCED RIGHT LEG DISCOMFORT WHEN WALKING AND ASSOCIATED WEAKNESS AND NUMBNESS. FOUR DAYS LATER, THE PATIENT RECEIVED AN ARTERIAL DOPPLER EXAMINATION WHICH WAS NEGATIVE FOR PSEUDOANEURYSM. THE TEST REVEALED POOR BLOOD FLOW IN THE RIGHT LEG AND OCCLUSIVE FILLING DEFECT IN THE FEMORAL ARTERY. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND A PERIPHERAL ANGIOGRAM WAS PERFORMED. THROMBOSIS OF THE RIGHT EXTERNAL ILIAC ARTERY WAS DIAGNOSED AND RECANALIZATION ATTEMPTS WERE MADE; HOWEVER, SURGICAL CUT DOWN WAS NECESSARY. UNDER GENERAL ANESTHESIA, A THROMBECTOMY OF THE RIGHT COMMON FEMORAL AND RIGHT EXTERNAL ILIAC ARTERIES WERE PERFORMED. ORGANIZED AND FRESH CLOT FROM THE RIGHT ILIAC ARTERY WAS REMOVED AND BLOOD FLOW WAS RE-ESTABLISHED. THE PATIENT RETURNED TO THE FLOOR IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VIP MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 2069002

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R