BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEASE PERMANENT VENA CAVA FILTER

    MDR report key: 1058095 · Received June 5, 2008

    Report

    Report Number
    9610978-2008-00142
    Event Type
    Malfunction
    Date Received
    June 5, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 15, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DQO
    PMA / PMN Number
    K020316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MFG QUALITY PLAN (MQP). THIS REVIEW WAS EXTENDED TO SUBASSEMBLY PART NUMBER E7119075 WITH LOT NUMBER 0401080025 AND 0401080035. THIS REVIEW CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL. THIS PRODUCT WILL BE RETURN FOR EVAL AND TESTING. ADD'L INFO WILL BE SENT WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THT THE TIP OF THE BRITETIP SHEATH INTRODUCER (INCLUDED IN THE TRAPEASE KIT) WAS FOUND SLIGHTLY FRAYED WHEN DEVICE WAS TAKEN OUT OF THE PACKAGE. NONETHELESS THE USER CONTINUED USING THE DEVICE, HOWEVER, DURING INSERTION, THE TIP TURNED GRADUALLY OUTWARDS. CONSEQUENTLY THE DEVICE WAS NOT USE AND ANOTHER NEW SHEATH INTRODUCER (SI) WAS USED FOR THE PROCEDURE. THE INTENDED TARGET LESION WAS THE JUGULAR VEIN. THERE WAS NO VESSEL TORTUOSITY AND THE RATE OF STENOSIS AND CALCIFICATION IS UNK. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEASE PERMANENT VENA CAVA FILTER THROMBECTOMY SYSTEMS (DQO) DQO CORDIS EUROPA, N.V. NA R0108235

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK