BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENALI FEMORAL SYSTEM

    MDR report key: 18298080 · Received December 9, 2023

    Report

    Report Number
    2020394-2023-01183
    Event Type
    Malfunction
    Date Received
    December 9, 2023
    Date of Event
    March 17, 2023
    Report Date
    August 13, 2024
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    UDI-DI
    00801741040825
    PMA / PMN Number
    K130366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUR FIRM RECEIVED AN FDA EMAIL CORRESPONDENCE ON 06-AUG-2024 FROM MDR DATA SYSTEMS TEAM, CIAUNDRIA SAVOY, INDICATING THAT THE INFORMATION (SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D) OF THE PREVIOUSLY SUBMITTED FDA FORM 3500A, WAS INCORRECT AND A REQUEST WAS MADE TO SUBMIT SUPPLEMENTAL REPORT(S) WITH THE ENTIRE UDI NUMBER INCLUDING THE DI AND PI FIELDS, ALL NUMBERS, LETTERS, PARENTHESES, AND SYMBOLS IN THE ¿UNIQUE DEVICE IDENTIFIER (UDI) #¿ FIELDS. THIS SUPPLEMENTAL REPORT IS IN RESPONSE TO THAT REQUEST. **UDI RELATED DATA QUALITY UPDATES ONLY** THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE DENALI PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510K NUMBER FOR THE SIMILAR DENALI PRODUCT IS IDENTIFIED IN D2 (PROCODE) AND G4 (PMA/510(K)). D4: MEDICAL DEVICE EXPIRATION DATE- 2025-08-28. D4: UDI-(B)(4). G4: K240257, K160866, K143208, K130366. H4: DEVICE MANUFACTURER DATE: 2022-09-01.

    Additional Manufacturer Narrative · 0

    H10: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US, BUT IS SIMILAR TO THE DENALI FILTER PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510K NUMBER FOR THE DENALI FILTER PRODUCTS IS IDENTIFIED IN D2 AND G4. 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: ONE DENALI FEMORAL DELIVERY SYSTEM WAS RETURNED, AND ONE PHOTO WAS PROVIDED AND REVIEWED. THE PHOTO SHOWS THE INTRODUCER SHEATH, THE DILATOR, THE PUSHER CATHETER, TOUHY ADAPTER AND THE PUSHER CATHETER INSERTED INSIDE THE STORAGE TUBE OF THE DENALI FILTER. THE FILTER WAS SEEN INSIDE THE STORAGE TUBE. VISUAL EVALUATION OF THE RETURNED DEVICE SHOWED THE INTRODUCER SHEATH WAS ATTACHED TO THE TOUHY/STORAGE TUBE. FILTER WAS SEATED WITHIN THE STORAGE TUBE. DISTAL TIP OF DILATOR WAS NOTED TO THE DAMAGE. UPON FUNCTIONAL TEST, TOUHY-BORST ADAPTER WAS UNSCREWED FROM STORAGE TUBE, AND FILTER WAS REMOVED MANUALLY FROM THE PROXIMAL END USING IN-HOUSE TWEEZERS. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FAILURE TO ADVANCE AS THE FILTER WAS NOTED TO BE IN THE STORAGE TUBE. THE INVESTIGATION IS ALSO CONFIRMED FOR THE IDENTIFIED DEFORMATION DUE TO COMPRESSIVE STRESS ISSUE AS THE DISTAL TIP OF DILATOR WAS NOTED TO DAMAGED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE TO ADVANCE AND IDENTIFIED DEFORMATION DUE TO COMPRESSIVE STRESS ISSUES 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: D4 (EXPIRATION DATE: 08/2025). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A FILTER PLACEMENT PROCEDURE, RESISTANCE WAS MET WHEN DELIVERING THE FILTER. IT WAS FURTHER REPORTED THAT THE FILTER ALLEGEDLY GOT STUCK IN THE DELIVERY SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A FILTER PLACEMENT PROCEDURE, RESISTANCE WAS MET WHEN DELIVERING THE FILTER. IT WAS FURTHER REPORTED THAT THE FILTER ALLEGEDLY GOT STUCK IN THE DELIVERY SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769567 DENALI FEMORAL SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFGW1539 00801741040825

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown