BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G2 FILTER SYSTEM - JUGULAR

    MDR report key: 1712807 · Received June 3, 2010

    Report

    Report Number
    2020394-2010-00181
    Event Type
    Injury
    Date Received
    June 3, 2010
    Date of Event
    May 7, 2010
    Report Date
    May 7, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K052578
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MFG PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND IN THE RECORDS TO INDICATE THERE WAS A MFG RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER. THE FILTER HAS BEEN RETAINED BY THE USER FACILITY; THEREFORE, NOT AVAILABLE FOR EVAL. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY. (B) (4). (B) (4). (B) (4). BARD G2 FILTER SYSTEM. RETRIEVABLE VENA CAVE FILTER. (B) (6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO MONTHS AFTER IMPLANT AND DURING AN UNSUCCESSFUL FILTER RETRIEVAL, IT WAS IDENTIFIED THAT A FILTER LIMB HAD DETACHED AND WAS LOCATED IN THE PT'S RIGHT VENTRICLE. THE FILTER WAS PLACED IN A SUPRARENAL LOCATION IN A (B) (6) PREGNANT WOMAN WITH A 1 MONTH HISTORY OF DVT AND MAY-THURNER SYNDROME. IT WAS REPORTED THAT AFTER THE FILTER WAS IMPLANTED, THE PT EXPERIENCED A PROLONGED 9 HOURS OF LABOR. SEVEN DAYS AFTER THE FIRST RETRIEVAL ATTEMPT, A SECOND ATTEMPT WAS MADE TO RETRIEVE THE DETACHED LIMB, BUT ALSO WAS UNSUCCESSFUL. THE DETACHED LIMB AND FILTER WERE SURGICALLY REMOVED AT ANOTHER FACILITY. THE PT IS RECOVERING FROM SURGERY. ADD'L INFO FROM THE USER FACILITY REPORT: THE PT WAS ADMITTED TO (B) (6) HOSP ON (B) (6) 2010 WITH A DVT. AT THAT TIME SHE WAS (B) (6) PREGNANT. ON (B) (6) 2010 A G2 BARD REMOVABLE SUPRARENAL RETRIEVABLE VENA CAVA FILTER WAS PLACED BY ULTRASOUND-GUIDED RIGHT JUGULAR VEIN ACCESS. SHE DELIVERED ON (B) (6) 2010. SHE HAD A PROLONGED, 9 HR LABOUR WITH SUCTION EXTRACTION. ON (B) (6) 2010, IN THE RADIOLOGY DEPT, AN ATTEMPT WAS MADE TO REMOVE THE FILTER AS PLANNED. AT THAT TIME IT WAS DISCOVERED THAT THE FILTER HAD BROKEN APART AND TRAVELED, LEAVING ONE STRUT OF THE FILTER IN THE RIGHT VENTRICLE AND TWO STRUTS STILL ATTACHED TO THE APEX OF THE FILTER. THE APEX OF THE FILTER WAS POSITIONED AT THE OPENINGS OF THE RIGHT AND LEFT RENAL VEINS WITH ONE STRUT IN BOTH VEINS AND A PIECE OF THE APEX PROTRUDING FROM HER VESSELS. A SECOND UNSUCCESSFUL ATTEMPT WAS MADE TO RETRIEVE THESE FOREIGN OBJECTS IN THE RADIOLOGY DEPT ON (B) (6) 2010. THE FILTER AND DETACHED STRUT WERE SURGICALLY REMOVED ON (B) (6) 2010 AT MEDICAL CENTER (B) (6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 FILTER SYSTEM - JUGULAR DTK BARD PERIPHERAL VASCULAR, INC. GFRB0414

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| L| R