BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENALI FEMORAL SYSTEM

    MDR report key: 18081509 · Received November 7, 2023

    Report

    Report Number
    2020394-2023-00994
    Event Type
    Malfunction
    Date Received
    November 7, 2023
    Date of Event
    September 23, 2022
    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- 2025-02-28; D4: UDI - (B)(4); G4: K240257, K160866, K143208, K130366; H4: DEVICE MANUFACTURER DATE: 2022-03-11.

    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 PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE DENALI PRODUCTS ARE IDENTIFIED IN D2 AND G4. H10: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: ONE DENALI FEMORAL DELIVERY SYSTEM WAS RETURNED AND TWO PHOTOS WAS PROVIDED AND REVIEWED. THE PHOTO SHOWS THE PUSHER CATHETER, ONE DILATOR, AND TWO INTRODUCER SHEATHS. ONE IS A FEMORAL INTRODUCER SHEATH (GREEN) AND THE OTHER IS A JUGULAR INTRODUCER SHEATH (WHITE). THE PUSHER CATHETER WAS INSERTED INTO THE STORAGE TUBE. VISUAL EVALUATION OF THE RETURNED DEVICE SHOWED PUSHER CATHETER WAS LOADED INTO TOUHY AND STORAGE TUBE. DISTAL TIP OF THE DILATOR WAS APPEARED TO BE DAMAGED. DURING FUNCTIONAL TEST, THE DETACHED PUSHER WIRE AND THE FILTER WAS REMOVED FROM THE STORAGE TUBE AND FILTER LEGS WERE PRESENT HOWEVER MULTIPLE LEGS WERE NOTED TO BE DAMAGED/BENT. BASED ON THESE FINDINGS THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FAILURE TO ADVANCE ISSUE AS THE FILTER WAS RECEIVED INSIDE THE STORAGE TUBE. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED DEFORMATION DUE TO COMPRESSIVE STRESS ISSUE AS THE DISTAL TIP OF THE DILATOR WAS NOTED TO BE DAMAGED. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL BENT ISSUE AS THE MULTIPLE LEGS WERE NOTED TO BE DAMAGED/BENT. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED DETACHMENT ISSUE AS THE PUSHER WIRE WAS DETACHED INSIDE THE STORAGE TUBE. ALTHOUGH IT IS LIKELY THE IDENTIFIED PUSHER WIRE DETACHMENT AND MULTIPLE LEGS WERE NOTED TO BE DAMAGED/BENT LED TO THE ALLEGED ADVANCEMENT ISSUE. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED ADVANCEMENT ISSUE AND IDENTIFIED PUSHER WIRE DETACHMENT, DEFORMATION DUE TO COMPRESSIVE STRESS AND MATERIAL BENT OR TWIST ISSUE 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 (EXPIRY DATE: 02/2025). 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, THE FILTER ALLEGEDLY HAD FAILURE TO ADVANCE. 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, THE FILTER ALLEGEDLY HAD FAILURE TO ADVANCE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247378 DENALI FEMORAL SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFGP0358 00801741040825

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown