BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6000036-1999-00175

    MDR report key: 257066 · Received December 28, 1999

    Report

    Report Number
    6000036-1999-00175
    Event Type
    Malfunction
    Date Received
    December 28, 1999
    Date of Event
    July 8, 1999
    Report Date
    December 17, 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. AN ATTEMPT TO RETRIEVE THE FILTER WITH A SNARE WAS UNSUCCSSFUL. ANOTHER FILTER WAS SUCCESSFULLY PLACED WITHOUT PATIENT COMPLICATIONS. IT WAS INDICATED THIS FILTER THEN MIGRATED INSIDE THE SECOND FILTER. THE PHYSICIAN FEELS THE PATIENT IS PROTECTED AND NO FURTHER ACTION WAS TAKEN. THIS DEVICE REMAINS IMPLANTED. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. FOLLOW-UP INDICATED THROMBUS WAS NOTED AT THE IMPLANT 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 RECURRENT PE...IF THROMBUS IS PRESENT IN THE RIGHT FEMORAL VEIN, ILIAC VEIN OR INFERIOR VENA CAVA, THE RIGHT INTERNAL JUGULAR SHOULD BE THE NEXT CHOICE FOR CATHETER INSERTION."

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN