BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIEVER16

    MDR report key: 19715792 · Received July 10, 2024

    Report

    Report Number
    3020347218-2024-00031
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    June 11, 2024
    Report Date
    September 19, 2024
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    PMA / PMN Number
    K211013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IDENTIFIERS WERE NOT PROVIDED, HOWEVER, THE LOT HISTORY RECORDS OF ALL POTENTIAL LOTS SHIPPED TO THE FACILITY WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. THE DEVICE WAS 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 TREIVER16 (T16) WAS RETURNED INSIDE THE CLOTTRIEVER SHEATH (16FR) (CT SHEATH) TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION OF THE T16 CONFIRMED THE DEVICE WAS UNRAVELED AND THE COIL WAS STRETCHED. VISUAL INSPECTION OF THE CT SHEATH REVEALED NO DAMAGE TO THE SHEATH NOR THE FUNNEL. INVESTIGATION OF BOTH DEVICES CONCLUDED THAT THE T16 BROKE LIKELY DUE TO EXCESSIVE FORCE USED DURING THE PROCEDURE. THE DEVICE IDENTIFIERS WERE NOT PROVIDED, HOWEVER, THE LOT HISTORY RECORDS OF ALL POTENTIAL LOTS SHIPPED TO THE FACILITY WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. ADDITIONALLY, A COMPLAINT HISTORY REVIEW WAS CONDUCTED WITH THE POTENTIAL LOTS SHIPPED AND NO SIMILAR ISSUES HAVE BEEN REPORTED AGAINST THE LOT NUMBERS. THE DEVICE LABELING INCLUDES THE FOLLOWING WARNING STATEMENT: "AVOID USING EXCESSIVE FORCE TO ADVANCE OR RETRACT AGAINST RESISTANCE. IF EXCESSIVE RESISTANCE OCCURS, RETRACT, AND REMOVE THE DEVICE. EXCESSIVE FORCE AGAINST RESISTANCE MAY RESULT IN DAMAGE TO THE DEVICE OR VESSEL PERFORATION. THE DEVICE LABELING RECOMMENDS THE USE OF A 22 FR INTRODUCER SHEATH. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2024, AN 85-YEAR-OLD FEMALE PATIENT WITH DEEP VEIN THROMBOSIS (DVT) UNDERWENT DVT THROMBECTOMY USING INARI DEVICES. THE ESTIMATED CLOT AGE WAS 60 DAYS. DURING THE THROMBECTOMY, THE TRIEVER16 (T16) WAS ADVANCED INTO THE PATIENT'S COMMON FEMORAL VEIN FROM THE POPLITEAL VEIN WITH THE DILATOR. THE PHYSICIAN NOTICED TIGHTNESS AS THE T16 WAS WALKED BACK. AS THE T16 WAS PULLED THROUGH THE CLOTTRIEVER SHEATH, 16 FR (CT SHEATH), THE T16 SNAPPED AND BEGAN TO UNRAVEL. THE CT SHEATH AND REMAINING PART OF THE T16 WERE REMOVED TOGETHER FROM THE PATIENT. THE DEVICES WERE REMOVED COMPLETELY FROM THE PATIENT WITHOUT INCIDENT AND WITHOUT ANY RESULTING PATIENT INJURY OR VESSEL DAMAGE. THE CASE WAS COMPLETED, AND NO FURTHER INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040860 TRIEVER16 PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 25-101

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female CLOTTRIEVER SHEATH, 16 FR.