BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 3213904 · Received July 3, 2013

    Report

    Report Number
    3003681312-2013-00035
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 10, 2013
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO INC
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FINAL MEDWATCH WILL BE SUBMITTED AT THE CONCLUSION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED TO SJM INDICATED A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE. AFTER THE ANCHOR HAD BEEN POSITIONED, THE CARRIER TUBE COULD NOT BE RETRACTED. PROPER ANCHOR POSITION WAS CONFIRMED BY ULTRASOUND AND SURGERY WAS REQUIRED TO REMOVE THE DEVICE AND THE WOUND WAS CLOSED WITH SUTURES. SURGICAL INTERVENTION TOOK APPROX ONE AND A HALF HOURS AND HOSPITALIZATION WAS EXTENDED. MANUAL COMPRESSION WAS ALSO APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304469 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL PUERTO RICO INC NA 3978457

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R