BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1000462 · Received February 21, 2008

    Report

    Report Number
    3003681312-2008-00016
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 23, 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
    JA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP MEDWATCH WILL BE SUBMITTED AT THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE TIME WAS 2 HOURS. A 6F TERUMO SHEATH AND 6F MEDTRONIC LAUNCHER CORONARY CATHETERS WERE USED. THE LEFT FEMORAL ARTERY WAS THE PROCEDURE ACCESS SITE. A CYPHER STENT WAS PLACED AT THE RIGHT CORONARY (RCA) - LEFT ANTERIOR DESCENDING (LAD) ARTERY LESION. A PRE-DEPLOYMENT ANGIOGRAM REVEALED NO ANOMALIES IN THE ARTERY. A 6F ANGIO-SEAL STS PLUS WAS DEPLOYED. HEMOSTASIS WAS NOT ACHIEVED AND MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THE PERIPHERAL ARTERY PULSE WAS NOT PALPABLE AND AN ULTRASOUND WAS PERFORMED. THE ULTRASOUND CONFIRMED THAT THE ENTIRE DEVICE WAS INTRA-ARTERIAL. THE ANCHOR, SUTURE AND COLLAGEN OF THE ANGIO-SEAL WERE REMOVED BY SURGICAL INTERVENTION. THE PT REMAINS HOSPITALIZED.

    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, PUERTO RICO, B.V. NA 2029579

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention