BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOTTRIEVER SHEATH

    MDR report key: 7083936 · Received December 5, 2017

    Report

    Report Number
    3011525976-2017-00002
    Event Type
    Injury
    Date Received
    December 5, 2017
    Date of Event
    November 7, 2017
    Report Date
    December 5, 2017
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    DXE
    UDI-DI
    00850291007109
    PMA / PMN Number
    K163549
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO INARI AND SUBJECTED TO VISUAL INSPECTION. THE FINDINGS CONFIRMED THAT THE DILATOR HUB HAD BEEN CUT BY THE PHYSICIAN AS DESCRIBED, BUT THERE WERE NO ANOMALIES OR DEVICE DEFECTS OBSERVED. THE CONDITION OF THE RETURNED DEVICE PRECLUDED FURTHER ANALYSIS (E.G., DIMENSIONAL ANALYSIS, PERFORMANCE TESTING). THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO ANOMALIES, DISCREPANCIES, OR NON-CONFORMANCES. THE ROOT CAUSE OF THE EVENT WAS BELIEVED TO BE RELATED TO USE ERROR WHERE THE DEVICE WAS DEPLOYED IN A VESSEL THAT WAS SMALLER THAN THE MANUFACTURER'S RECOMMENDATIONS. THE DEVICE LABELING LISTS THE FOLLOWING CONTRAINDICATION: "NOT INTENDED FOR USE IN VESSELS < 6 MM." (B)(4).

    Description of Event or Problem · 1

    A PATIENT REQUIRED INTERVENTION TO TREAT BILATERAL DEEP VEIN THROMBOSIS (DVT) AFTER PREVIOUS ANGIOJET AND 24-HOUR TPA DRIP USING EKOS DEVICE. THE PHYSICIAN SUCCESSFULLY TREATED THE PATIENT'S LEFT DVT BY ASPIRATION WITH AN 8 FR CATHETER. ON THE RIGHT SIDE, THE PHYSICIAN INSERTED THE INARI CLOTTRIEVER SHEATH, MODEL 50-101, IN THE PATIENT'S RIGHT POPLITEAL VEIN MEASURING 4-5 MM IN DIAMETER VIA VENOGRAM. AFTER SUCCESSFULLY DEPLOYING THE FUNNEL BY ADVANCING THE DILATOR, THE PHYSICIAN WAS UNABLE TO WITHDRAW THE DILATOR THROUGH THE CLOTTRIEVER SHEATH. THE PHYSICIAN RETRACTED BOTH THE CLOTTRIEVER SHEATH AND DILATOR UNTIL THE SHEATH EXITED THE VESSEL, BUT THE DILATOR REMAINED IN THE VESSEL. THE PHYSICIAN INTERVENED TO CUT THE DILATOR HUB, THEN WITHDREW THE CLOTTRIEVER SHEATH FROM THE ACCESS SITE. USING A 14 FR SHEATH, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE DILATOR FROM THE PATIENT WITHOUT DAMAGING THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861628 CLOTTRIEVER SHEATH EMBOLECTOMY CATHETER DXE INARI MEDICAL, INC. 50-101 17050006 00850291007109

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention