BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMON NITINOL VENA CAVA FILTER

    MDR report key: 32594 · Received January 10, 1995

    Report

    Report Number
    1018233-1994-00099
    Event Type
    Injury
    Date Received
    January 10, 1995
    Date of Event
    December 16, 1994
    Report Date
    December 16, 1994
    Manufacturer
    NITINOL MED TECHNOLOGIES, INC.
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    AFTER POSITIONING THE INTRODUCER CATHETER INTO THE PT'S VESSEL AND ATTACHING THE DELIVERY SYSTEM, THE DOME DIDN'T FORM PROPERLY FOR DEPLOYMENT. WHEN THE DOME EXITED THE INTRODUCER SHEATH, THE TIP OF THE DOME TURNED DOWN INSTEAD OF UP. ANOTHER PUNCTURE WAS MADE ALONG SIDE THE INITIAL ENTRY SITE AND A GOOSENECK SNARE WAS USED TO PULL THE DOME'S TIP OUT TO FORM THE DOME CORRECTLY. ONCE THIS WAS DONE, DEPLOYMENT OF THE FILTER WAS COMPLETED TO THE TARGETED LOCATION WITH NO FURTHER COMPLICATIONS REPORTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMON NITINOL VENA CAVA FILTER VENA CAVA FILTER DTK NITINOL MED TECHNOLOGIES, INC. NA 03-054728

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention