BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTION RETRIEVABLE VENA CAVA FILTER SYSTEM

    MDR report key: 1631223 · Received March 12, 2010

    Report

    Report Number
    3003862657-2010-00001
    Event Type
    Other
    Date Received
    March 12, 2010
    Date of Event
    February 6, 2010
    Report Date
    March 11, 2010
    Manufacturer
    REX MEDICAL, L.P.
    Product Code
    DTK
    PMA / PMN Number
    K081410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED TO OBTAIN ANY AND ALL INFORMATION PERTAINING TO THE OPTION FILTER PLACEMENT. A REVIEW BY THE REX MEDICAL ENGINEERING TEAM AS WELL AS REX MEDICAL MANAGEMENT OF THE FILTER KIT COMPONENTS THAT WERE RETURNED TO REX MEDICAL AS WELL AS A FACE TO FACE MEETING BETWEEN DR. (B)(6) ((B)(6)) AND (B)(4) ((B)(4) - REX MEDICAL) FOUND THAT DR. (B)(6) HAD ATTACHED THE FILTER CARTRIDGE INADVERTENTLY UPSIDE DOWN WHICH LEAD TO THE OPTION VENA CAVA FILTER BEING PLACED IMPROPERLY WITHIN THE PATIENT. THE OPTION VENA CAVA FILTER COMES PRE-LOADED IN A CARTRIDGE WHICH ALLOWS IT TO BE PLACED FROM EITHER A JUGULAR OR FEMORAL APPROACH. THE CARTRIDGE IS LABELED TO INDICATE THE DIRECTION OF PLACEMENT; "JUGULAR" WITH A DIRECTIONAL ARROW IN BLUE INK; "FEMORAL" WITH A DIRECTIONAL ARROW IN GREEN INK. WHEN ATTACHING THE CARTRIDGE TO THE DELIVERY SYSTEM PRIOR TO FILTER DEPLOYMENT, DR. (B)(6) ATTACHED THE CARTRIDGE TO THE DELIVERY SYSTEM WITH THE "FEMORAL" PRINTING AND DIRECTIONAL ARROW POINTING TOWARDS THE DELIVERY SHEATH (INSTEAD OF "JUGULAR" AND THE DIRECTIONAL ARROW POINTING TOWARDS THE DELIVERY SHEATH). ONCE IT WAS NOTICED THAT THE FILTER WAS PLACED UPSIDE DOWN, AN ATTEMPT WAS MADE TO REMOVE THE FILTER FROM THE PATIENT WHICH WAS UNSUCCESSFUL. THE FILTER WAS SNARED AND BROUGHT INTO THE RETRIEVAL SHEATH BUT BECAME UN-SNARED AND RE-DEPLOYED INTO THE FEMORAL VEIN. THIS THEN REQUIRED SURGICAL INTERVENTION TO REMOVE THE FILTER. THIS APPEARS TO BE A USER ERROR ISOLATED INCIDENT.

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING AN OPTION VENA CAVA FILTER PLACEMENT ON A FEMALE PATIENT VIA THE RIGHT INTERNAL JUGULAR AND PROCEEDED TO DEPLOY THE FILTER UPSIDE DOWN. ONCE THIS WAS NOTICED, THE PHYSICIAN ATTEMPTED TO REMOVE THE FILTER. THE FILTER WAS SNARED AND BROUGHT INTO THE RETRIEVAL SHEATH BUT SOMEHOW BECAME UN-SNARED AND REDEPLOYED INTO THE FEMORAL VEIN. THIS THEN REQUIRED SURGICAL INTERVENTION TO REMOVE THE FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTION RETRIEVABLE VENA CAVA FILTER SYSTEM INFERIOR VENA CAVA FILTER DTK REX MEDICAL, L.P. 352506070 S30096

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention