BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS

    MDR report key: 512735 · Received February 24, 2004

    Report

    Report Number
    2182269-2004-00031
    Event Type
    Injury
    Date Received
    February 24, 2004
    Date of Event
    July 31, 2003
    Report Date
    February 24, 2004
    Manufacturer
    ST. JUDE MEDICAL, DAIG DIVISION, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED AN ANGIO-SEAL DEVICE WAS DEPLOYED FOLLOWING A DIAGNOSTIC ANGIOGRAM IN 2003. THE PT COMPLAINED OF PAIN DURING DEPLOYMENT. FOLLOWING THE POINT OF ANCHOR DEPLOYMENT, THE PHYSICIAN WAS UNABLE TO PULL THE DEVICE BACK AND OUT. THE PT UNDERWENT SURGERY TO REMOVE THE ANGIO-SEAL DEVICE. FOLLOWING SURGERY, A STRONG PULSE WAS PALPABLE AT THE FEMORAL PROFUNDA AND SUPERFICIAL FEMORAL ARTERIES. THE SITE WAS FLUSHED AND A REDON DRAIN WAS PLACED. THE PT WAS REPORTEDLY IN STABLE CONDITION. THE DIAGNOSTIC ANGIOGRAM REVEALED NON-DILATED LEFT VENTRICLE, EJECTION FRACTION 48%, ANTERIOR WALL APEX ANEURYSM, TORTUOSITY RELATED TO HYPERTENSIVE HEART DISEASE. THE PT HAD SINGLE VESSEL CORONARY ARTERY DISEASE; MEDICAL TREATMENT WAS PROPOSED. A FOLLOW-UP CONSULT WITH THE PHYSICIAN A WEEK LATER REVEALED A RESOLVING HEMATOMA AND A RECOMMENDATION TO REMOVE THE STITCHES TWO DAYS LATER. THE PT SUFFERED FROM PARASTHESIA AND MOTOR NEURALGIA, INDICATING LOCAL NERVE IRRITATION AT THE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS 6F ANGIO-SEAL STS MGB ST. JUDE MEDICAL, DAIG DIVISION, INC. NA 03DD13

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR HEPARIN 5000 IU, PROTAMINE 2ML, 2003,| CLOPIDOGREL 27 MG, VALSARTAN 80 MG, CARVEDILOL| 6.25 MG, VITAMIN B, SIMVASTATIN 20 MG, IBUPROFEN| IN CASE OF PAIN.