BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1895395 · Received November 4, 2010

    Report

    Report Number
    2182269-2010-00207
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 19, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) STATES SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. NO PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THE IFU ALSO 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 THAT A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE POST PERCUTANEOUS CORONARY ANGIOGRAM (CAG) TO CLOSE THE RIGHT FEMORAL ARTERIOTOMY. THERE WERE NO REPORTED DEPLOYMENT ISSUES AND THE PATIENT WAS TRANSFERRED OFF THE TABLE. ONE HOUR LATER THE PATIENT EXPERIENCED A LOSS OF FEELING IN HER RIGHT LEG. AN ULTRASOUND, A CT SCAN, AND AN ANGIOGRAM WERE PERFORMED AND DIAGNOSED A VESSEL OCCLUSION. THE PATIENT WAS STARTED ON HEPARIN AND TRANSFERRED TO ANOTHER HOSPITAL WHERE SURGICAL INTERVENTION WAS PERFORMED. THE SURGEON REPORTED THAT A DISSECTION WAS OCCLUDING THE FEMORAL ARTERY. THE ANGIO-SEAL WAS REMOVED AND THE PATIENT WAS REPORTED TO BE RECOVERING 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 NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R