BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENALI FEMORAL SYSTEM

    MDR report key: 19708252 · Received July 10, 2024

    Report

    Report Number
    2020394-2024-01006
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    June 13, 2024
    Report Date
    August 12, 2024
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    UDI-DI
    00801741040801
    PMA / PMN Number
    K130366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: RECEIVED ONE DENALI FEMORAL FILTER FOR EVALUATION. PRODUCT PACKAGING AND LABEL WERE RETURNED, AND PRODUCT INFORMATION WAS VERIFIED WITH TRACKWISE. DURING VISUAL EVALUATION, APPEARED TO HAVE BLOOD RESIDUE AND TISSUE THROUGHOUT. THE FILTER WAS RECEIVED DEPLOYED. FILTER LIMBS WERE PRESENT, AND NO LEGS WERE CROSSED. FUNCTIONAL TESTING WAS NOT PERFORMED. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED ACTIVATION FAILURE INCLUDING EXPANSION FAILURES AS THE CONDITIONS DURING USE ARE UNKNOWN. A DEFINITIVE ROOT CAUSE FOR THE ACTIVATION FAILURE INCLUDING EXPANSION FAILURES COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. H10: B5, D4 (EXPIRATION DATE: 05/2027). H11: H6 (METHOD, RESULT, CONCLUSION). H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRY DATE: 05/2027) H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A VENA CAVA FILTER PLACEMENT PROCEDURE VIA THE FEMORAL ARTERY, THE FILTER ALLEGEDLY WOULD NOT BE OPENED UP. IT WAS FURTHER REPORTED THE FILTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A VENA CAVA FILTER PLACEMENT PROCEDURE VIA FEMORAL ARTERY, THE FILTER WAS ALLEGEDLY WOULD NOT OPEN UP. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478213 DENALI FEMORAL SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFJR0199 00801741040801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown