BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 2251218 · Received September 12, 2011

    Report

    Report Number
    3003681312-2011-00064
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    July 19, 2011
    Report Date
    September 9, 2011
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 6F ANGIO-SEAL STS PLUS HEMOSTASIS SHEATH AND CARRIER TUBE ASSEMBLY WERE VISUALLY INSPECTED; THE COLLAGEN WAS NOT RETURNED. THE CARRIER TUBE ASSEMBLY HAD BEEN FULLY INSERTED INTO THE HEMOSTASIS SHEATH AND WAS IN FULL REAR LOCK POSITION. A 1.2" LENGTH OF SUTURE EXITED THE SHEATH DISTAL TIP; THE SUTURE DISTAL END WAS CONSISTENT WITH CUTTING. NO VISUAL ANOMALIES WERE NOTED. THE OVERALL DEVICE CONDITION WAS CONSISTENT WITH DEPLOYMENT. 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.

    Description of Event or Problem · 1

    THE ANCHOR OF A 6F STS+ ANGIO-SEAL DEVICE WAS DEPLOYED AND WAS ALLEGEDLY FREE IN THE ARTERY. NO THROMBOSIS OCCURRED. HOWEVER, THE PT'S HOSPITALIZATION WAS EXTENDED TO MAKE SURE THAT NO THROMBOSIS OCCURRED. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL PUERTO RICO, B.V. NA 3315876

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization