BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENALI FEMORAL SYSTEM

    MDR report key: 3881457 · Received February 19, 2014

    Report

    Report Number
    2020394-2014-00048
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 23, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K130366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO ENSURE COMPLIANCE TO 21 CFR 803.50 A RETROSPECTIVE REVIEW OF THIS FILE WAS CONDUCTED TO DETERMINE IF GOOD FAITH EFFORTS WERE MADE TO OBTAIN THE REQUIRED INFORMATION AND/OR AN EXPLANATION OF WHY ANY REQUIRED INFORMATION WAS NOT PROVIDED. THIS FILE INDICATED ATTEMPTS WERE MADE TO THE FACILITY TO OBTAIN INFORMATION PERTAINING TO PATIENT, PRODUCT, AND/OR PROCEDURAL DETAILS (E.G. DATE OF THE EVENT, RELEVANT TEST DATA, RELEVANT HISTORY, LOT #, CATALOG #, IMPLANT AND/OR EXPLANTED DATES, AND CONCOMITANT PRODUCT(S) OR THERAPY). THE FILE DID RECEIVE SOME PATIENT DETAILS AND AN ADDITIONAL ATTEMPT WAS MADE WITH INTERNATIONAL REPRESENTATIVE REGARDING PATIENT INFORMATION MISSING FROM THE FILE. THE INTERNATIONAL REPRESENTATIVE ADVISED THAT (B)(6) HAS A PRIVACY LAWS THAT PROHIBITS THE TRANSFER OF PATIENT DATA. THEREFORE, THE REMAINING PATIENT DETAILS ARE UNOBTAINABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE FILTER WAS RETURNED AND ALL MEASUREMENTS ME ALL THE REQUIRED SPECIFICATIONS. THE COMPLAINT INVESTIGATION IS INCONCLUSIVE, AS IMAGES WERE NOT PROVIDED FOR REVIEW. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNK. IT IS UNK IF PT OR PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS AFTER IMPLANTATION OF A VENA CAVA FILTER, CT IMAGING DEMONSTRATED SOME CROSSED FILTER LEGS. THE FILTER WAS SUCCESSFULLY RETRIEVED. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104213 DENALI FEMORAL SYSTEM DTK BARD PERIPHERAL VASCULAR, INC. GFX3687

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR