BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JETI PERIPHERAL THROMBECTOMY SYSTEM, STERILE DISPOSABLE COMPONENTS KIT

    MDR report key: 16628556 · Received March 28, 2023

    Report

    Report Number
    2024168-2023-03103
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Date of Event
    February 1, 2023
    Report Date
    May 10, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    QEZ
    PMA / PMN Number
    K213565
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. DEVICE CODE 2017 USE AFTER EXPIRATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED ACTIVATION FAILURE WAS NOT CONFIRMED AS THE DEVICE PERFORMED AS EXPECTED. THE KINKED CATHETER WAS CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. THE DEVICE WAS USED AFTER THE EXPIRATION DATE. REVIEW OF THE LOT HISTORY RECORD INDICATED AN EXPIRATION DATE (USE BY DATE) OF 24-APRIL-2022 AND THE PROCEDURE DATE WAS 01-FEBRUARY-2023 WHICH IS 284 DAYS POST EXPIRATION. IT SHOULD BE NOTED THAT THE JETI PERIPHERAL THROMBECTOMY SYSTEM INSTRUCTIONS FOR USE (IFU), STATES: DO NOT USE IF THE EXPIRATION DATE HAS PASSED. IT IS UNKNOWN IF THE USE AFTER EXPIRATION CONTRIBUTED TO THE REPORTED EVENT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE THROMBECTOMY PROCEDURE WAS PERFORMED IN THE LEFT ILIAC VEIN. THE JETI 8FRENCH CATHETER WAS INSERTED INTO THE PATIENT ANATOMY; HOWEVER, WHEN THE FOOT PEDAL WAS PRESSED, THE CATHETER DID NOT RESPOND AND NO SUCTION OR SALINE SPRAY OCCURRED. THE DEVICE WAS REMOVED AND A LARGE KINK WAS SEEN. A REPLACEMENT JETI CATHETER WAS USED TO CONTINUE THE PROCEDURE. ADDITIONALLY, THE DEVICE WAS USED AFTER EXPIRATION DATE; HOWEVER, THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427004 JETI PERIPHERAL THROMBECTOMY SYSTEM, STERILE DISPOSABLE COMPONENTS KIT ASPIRATION THROMBECTOMY CATHETER QEZ ABBOTT VASCULAR 2004040

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown