BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECOVERY G2 FILTER SYSTEM - JUGULAR DELIVERY KIT

    MDR report key: 1642301 · Received March 23, 2010

    Report

    Report Number
    2020394-2010-00104
    Event Type
    Injury
    Date Received
    March 23, 2010
    Date of Event
    February 16, 2010
    Report Date
    February 24, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 QC 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 RETURNED FOR EVAL. THE INVESTIGATION IS CURRENTLY UNDERWAY. THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO ONE MARKETED IN THE UNITED STATES 510(K): K052578.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 DAYS AFTER FILTER IMPLANT, IT WAS IDENTIFIED THAT THE FILTER MIGRATED CAUDALLY AND WAS TILTED 90 DEGREES. THE FILTER WAS SUCCESSFULLY PLACED USING THE JUGULAR APPROACH. FIVE DAYS LATER, PRIOR TO A SCHEDULED RETRIEVAL, "PHLEBOGRAPHY" AND CT EXAM SHOWED MALPOSITION OF THE FILTER. IT WAS IDENTIFIED THAT THE FILTER HAD MIGRATED CAUDALLY, AND BECAME CAUGHT IN THE RENAL VEINS. THIS CAUSED THE FILTER TO TILT APPROX 90 DEGREES. THE ATTEMPTED RETRIEVAL WAS CANCELLED. HOWEVER, A SUBSEQUENT PROCEDURE WAS PERFORMED. THE APPROACH WAS VIA THE FEMORAL VEIN UTILIZING A LONG SHEATH. REPORTEDLY, THE PHYSICIANS WERE NOT ABLE TO COMPLETELY RETRACT THE FILTER INTO THE SHEATH. A CUTDOWN WAS PERFORMED AND THE FILTER WAS SUCCESSFULLY WITHDRAWN THROUGH THE FEMORAL VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECOVERY G2 FILTER SYSTEM - JUGULAR DELIVERY KIT DTK BARD PERIPHERAL VASCULAR, INC. GFRG4886

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention