BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9F PRUITT INAHARA OUTLYING SHUNT WITH T-PORT

    MDR report key: 3070612 · Received April 12, 2013

    Report

    Report Number
    1220948-2013-00004
    Event Type
    Injury
    Date Received
    April 12, 2013
    Report Date
    March 19, 2013
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    MJN
    PMA / PMN Number
    K043023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR THE EVALUATION. WE WERE NOT ABLE TO VERIFY THE FAILURE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND ALL MFG AND QUALITY INSPECTIONS WERE COMPLETED IN ACCORDANCE TO THE INSTRUCTIONS. BASED ON THE COMPLAINT DESCRIPTION WE COULD CONCLUDE THAT THE MOST PROBABLE ROOT CAUSES OF THE INCIDENT ARE THE EXTREMELY DISEASED VESSEL )PT ANATOMY) AND OVER INFLATING OF THE BALLOON. PLEASE NOTE THAT THE PT IS OKAY.

    Description of Event or Problem · 1

    DURING THE CEA PROCEDURE, THE PHYSICIAN INFLATED INTERNAL CAROTID BALLOON WITH SALINE. AT THAT TIME, THE BLOOD FLOW DID NOT STOP. THE PHYSICIAN CONTINUED TO INJECT THE SALINE ABOUT 4CC INTO THE BALLOON. (BALLOON MAXIMUM LIQUID CAPACITY IS .25 ML. AS A RESULT, THE BLOOD FLOW STOPPED AND THE PROCEDURE WAS COMPLETED. AT THE INSPECTION AFTER THE PROCEDURE, THE PHYSICIAN NOTICED THE DISSECTION IN THE INTERNAL VESSEL. THE VESSEL WAS REPAIRED AND THE PT IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158456 9F PRUITT INAHARA OUTLYING SHUNT WITH T-PORT PRUITT INAHARA SHUNT MJN LEMAITRE VASCULAR 2000-49 PIS1970

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O