BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENALI FEMORAL SYSTEM

    MDR report key: 18272563 · Received December 6, 2023

    Report

    Report Number
    2020394-2023-01141
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    August 20, 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. 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- 2025-11-28. D4: UDI-(B)(4). G4: K240257, K160866, K143208, K130366. H4: DEVICE MANUFACTURER DATE: 2022-12-01.

    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 FOR EVALUATION. SIX PHOTOS WERE PROVIDED AND REVIEWED. THE PHOTO SHOWS AN EMPTY FILTER STORAGE TUBE AND LOADS INTO THE INTRODUCER SHEATH AND PARTIAL VIEW OF PUSHER CATHETER WAS OBSERVED AND PUSHER WIRE NOTED TO BE DETACHED. VISUAL EVALUATION OF THE RETURNED DEVICE PUSHER WIRE NOTED TO BE DETACHED AND FILTER WAS OBSERVED WITHIN THE INTRODUCER SHEATH. BUNCHING WAS NOTED ON THE DISTAL PORTION OF THE INTRODUCER SHEATH. BASED ON THE FINDINGS THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FAILURE TO ADVANCE ISSUE AS THE FILTER WAS IN THE INTRODUCER SHEATH. THE INVESTIGATION IS ALSO CONFIRMED FOR THE IDENTIFIED DETACHED ISSUE AS THE PUSHER WIRE WAS DETACHED AND THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL DEFORMATION ISSUE AS BUNCHING WAS NOTED ON THE DISTAL PORTION OF THE INTRODUCER SHEATH. A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE TO ADVANCE AND IDENTIFIED DETACHED AND MATERIAL DEFORMATION 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: 11/2025) . 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 VENA CAVA FILTER PLACEMENT PROCEDURE VIA THE LEFT FEMORAL VEIN, THE FILTER ALLEGEDLY GOT STUCK DURING THE PROCESS OF PUSHING THE FILTER INTO THE GUIDE SHEATH. IT WAS FURTHER REPORTED THAT THE FILTER COULD NOT BE PUSHED TO THE FAR END OF THE GUIDE SHEATH NORMALLY, AND ALLEGEDLY FAILED AFTER SEVERAL ATTEMPTS. 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 THE LEFT FEMORAL VEIN, THE FILTER ALLEGEDLY GOT STUCK DURING THE PROCESS OF PUSHING THE FILTER INTO THE GUIDE SHEATH. IT WAS FURTHER REPORTED THAT THE FILTER COULD NOT BE PUSHED TO THE FAR END OF THE GUIDE SHEATH NORMALLY, AND ALLEGEDLY FAILED AFTER SEVERAL ATTEMPTS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2064921 DENALI FEMORAL SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFGY0244 00801741040825

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown