BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENALI FEMORAL SYSTEM

    MDR report key: 3881552 · Received May 30, 2014

    Report

    Report Number
    2020394-2014-00245
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 2, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K366130
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 WAS MISSING PATIENT DATA. SPOKE WITH INTERNATIONAL REPRESENTATIVE REGARDING PATIENT INFORMATION MISSING FROM THE FILE AND WAS ADVISED THAT (B)(6) HAS A PRIVACY LAW THAT PROHIBITS THE TRANSFER OF PATIENT DATA. THEREFORE, THE 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. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER FOR THESE FAILURE MODES. THE DEVICE WAS NOT RETURNED; THEREFORE, A SAMPLE EVALUATION COULD NOT BE PERFORMED. ONE IMAGE WAS PROVIDED. BASED UPON THE IMAGE REVIEW, THE COMPLAINT INVESTIGATION IS CONFIRMED FOR DEPLOYMENT ISSUES. THE INVESTIGATION IS INCONCLUSIVE FOR CROSSED FILTER LEGS. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. IT IS UNKNOWN IF PATIENT AND/OR PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEPLOYMENT OF A VENA CAVA FILTER, RESISTANCE WAS ENCOUNTERED DURING RETRACTION OF THE DELIVERY SHEATH AND THE FILTER LEGS WOULD NOT RELEASE FROM THE DELIVERY SYSTEM. ADDITIONAL MANIPULATION OF THE DELIVERY SYSTEM WAS USED TO COMPLETE THE DEPLOYMENT; HOWEVER, THE FILTER LEGS WERE CROSSED. THE FILTER REMAINS IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319529 DENALI FEMORAL SYSTEM DTK BARD PERIPHERAL VASCULAR, INC. GFXL2782

    Patients

    Seq Age Sex Outcome Treatment
    1