BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTEASE VENA CAVA FILTER

    MDR report key: 1161178 · Received September 15, 2008

    Report

    Report Number
    9610978-2008-00233
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 19, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DTK
    PMA / PMN Number
    K034050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, AS OF TO DATE, THE EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT UPON ENTRY OF THE OPTEASE RETRIEVAL FILTER INTO THE SHEATH, THE FILTER (BARBS) GOT STUCK IN THE SHEATH. THE ENTIRE SYSTEM WAS REMOVED AND A NEW OPTEASE SYSTEM WAS USED TO COMPLETE THE PROCEDURE. FURTHER INFORMATION INDICATED THAT WHEN THE PHYSICIAN PROCEEDED TO LOAD THE OPTEASE INTO THE LONG SHEATH, IT WOULD NOT ADVANCE ANY FURTHER THAN THE COMMON ILIAC AS IT BECAME STUCK IN THE SHEATH. AT THIS POINT, THE PHYSICIAN INCREASED THE PRESSURE WITH WHICH HE NORMALLY ADVANCES THE PRODUCT BUT IT WOULD NOT MOVE, THEREFORE, HE PULLED THE LONG SHEATH BACK TO THE COMMON FEMORAL ARTERY UNTIL THE OPTEASE CAME OUT OF THE ACCESS SITE. THE PHYSICIAN NOTED THAT THE HOOKS OF THE OPTEASE WERE COMING OUT OF THE SHEATH. THE PHYSICIAN INDICATED THAT HE HAD TO CUT THE LONG SHEATH AND REMOVE IT FROM THE WIRE. A NEW LONG SHEATH AND FILTER WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. THERE WAS NO HARM TO THE PATIENT. THE PATIENT'S ANATOMY WAS NOT TORTUOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS EUROPA, N.V. NA R0408452

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention