BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIEVER 24

    MDR report key: 19647191 · Received July 1, 2024

    Report

    Report Number
    3020347218-2024-00029
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 2, 2024
    Report Date
    September 4, 2024
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007185
    PMA / PMN Number
    K213402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IDENTIFIERS WERE PROVIDED, AND THE LOT HISTORY RECORDS WERE REVIEWED. THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. THE TRIEVER24 HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. MANUFACTURER REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 0

    THE TRIEVER24 (T24) WAS RETURNED TO THE MANUFACTURER AND EVALUATED. VISUAL INSPECTION OF THE DEVICE CONFIRMED THE MARKER BAND WAS NO LONGER ATTACHED TO THE CATHETER AND ADHESIVE RESIDUE WAS OBSERVED IN THE MARKER BAND'S ABSENCE. THE DEVICE ALSO HAD THREE LARGE KINKS IN THE CATHETER. THE FLOWTRIEVER 2 CATHETER (FT2) LIKELY COMPROMISED THE STRUCTURE OF THE T24 TIP, POSSIBLY DUE TO NOT BEING FULLY COLLAPSED WHEN ATTEMPTING TO PULL THE DEVICE THROUGH THE T24, WHEN THE FT2 CAUGHT ON THE T24. EXCESSIVE FORCE MAY HAVE BEEN USED TO PULL THE FT2 THOUGH THE T24, WHEN THE FT2 BECAME CAUGHT ON THE T24. THE MARKER BAND LIKELY DISLODGED DUE TO SUBSEQUENT USE OF THE T24 FOLLOWING THE MARKER BAND BEING COMPROMISED AFTER THE FT2 DISTAL END GOT CAUGHT ON THE T24 DURING USE. THE DEVICE IDENTIFIERS WERE PROVIDED, AND THE LOT HISTORY RECORDS WERE REVIEWED. THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. THERE HAVE BEEN NO SIMILAR COMPLAINT EVENTS FOR THIS LOT NUMBER. THE DEVICE LABELING INCLUDES THE FOLLOWING WARNING STATEMENT: "AVOID USING EXCESSIVE FORCE TO ADVANCE OR RETRACT AGAINST RESISTANCE. IF EXCESSIVE RESISTANCE IS ENCOUNTERED, RETRACT AND COLLAPSE THE FLOWTRIEVER DISK(S) INTO THE TRIEVER CATHETER AND REMOVE THE DEVICE. EXCESSIVE FORCE AGAINST RESISTANCE MAY RESULT IN DAMAGE TO THE DEVICE OR VESSEL PERFORATION" MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    A 20-YEAR-OLD FEMALE PATIENT WITH PULMONARY EMBOLISM (PE) AND CONCOMITANT DEEP VEIN THROMBOSIS (DVT), BEING TREATED WITH ANTICOAGULATION, UNDERWENT PE THROMBECTOMY WITH INARI DEVICES ON (B)(6) 2024. THE PE CLOT AGE WAS ESTIMATED AT 28 DAYS. DURING THROMBECTOMY, THE MEDICAL TEAM NOTICED THE FLOWTRIEVER 2 CATHETER (FT2) CAUGHT ON THE MARKER BAND OF THE TREIVER24 (T24,) THEN WHILE PULLING THE T24 BACK, THE MARKER BAND SEPARATED FROM THE T24 CATHETER AND REMAINED IN THE PATIENT'S INFERIOR VENA CAVA (IVC), STILL ON THE GUIDEWIRE. THE MARKER BAND WAS ASPIRATED AND RETRIEVED WITH A NEWLY OPENED T24 DEVICE. THE REMOVAL OF THE MARKER BAND PROLONGED THE SURGERY BY AN ADDITIONAL TEN MINUTES. THE CASE WAS CONCLUDED. THERE WAS NO RESULTING PATIENT INJURY. POSTOPERATIVELY, THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544223 TRIEVER 24 PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 22-101 24030018 00850291007185

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female AMPLATZ SUPER STIFF GUIDEWIRE.| FLOWTRIEVER 2 CATHETER, M.