BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENALI JUGULAR SYSTEM

    MDR report key: 18011494 · Received October 26, 2023

    Report

    Report Number
    2020394-2023-00938
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    October 4, 2023
    Report Date
    August 13, 2024
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    UDI-DI
    00801741040818
    PMA / PMN Number
    K130366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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- 2025-08-28D4: UDI-(01)00801741040818(11)220901(17)250828(10)GFGV1796G4: K240257, K160866, K143208, K130366H4: 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 JUGULAR SYSTEM PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE DENALI JUGULAR SYSTEM PRODUCTS ARE IDENTIFIED IN D2 AND G4. H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. H10: D4 (EXPIRY 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. H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A VENA CAVA FILTER PLACEMENT PROCEDURE VIA THE INTERNAL JUGULAR, THE SHEATH WAS ALLEGEDLY DIFFICULT TO BE INSERTED. IT WAS FURTHER REPORTED THAT THE SHEATH ALLEGEDLY PEELED OFF. THE PROCEDURE WAS COMPLETED BY 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 INTERNAL JUGULAR, THE SHEATH WAS ALLEGEDLY DIFFICULT TO BE INSERTED. IT WAS FURTHER REPORTED THAT THE SHEATH ALLEGEDLY PEELED OFF. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567699 DENALI JUGULAR SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFGV1796 00801741040818

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown