BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6000036-1999-00174

    MDR report key: 257053 · Received December 28, 1999

    Report

    Report Number
    6000036-1999-00174
    Event Type
    Malfunction
    Date Received
    December 28, 1999
    Date of Event
    November 19, 1999
    Report Date
    December 20, 1999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED A FILTER DID NOT APPEAR TO OPEN COMPLETELY FOLLOWING DEPLOYMENT VIA A FEMORAL APPROACH. ANOTHER FILTER WAS SUCCESSFULLY PLACED VIA A JUGULAR APPROACH WITHOUT PATIENT COMPLICATIONS. THIS DEVICE REMAINS IMPLANTED. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. FOLLOW-UP INDICATED THROMBUS WAS NOTED AT THE IMPANT SITE DURING A PRE-PLACEMENT CAVOGRAM. DEPLOYING THE FILTER IN THROMBUS MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. DIRECTIONS FOR USE STATE: "DO NOT ATTEMPT TO MOVE OR MANIPULATE AN ENGAGED FILTER...IN MOST CASES, A SECOND FILTER, PROPERLY PLACED, SHOULD BE IMPLANTED FOR PROTECTION AGAINST PE...IF THROMBUS IN THE RIGHT FEMORAL VEIN, ILIAC VEIN OR INFERIOR VENA CAVA, THE RIGHT INTERNAL JUGULAR VEIN SHOULD BE THE NEXT CHOICE FOR CATHETER INSERTION."

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN