BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOTTRIEVER SHEATH, 13 FR

    MDR report key: 23435584 · Received October 31, 2025

    Report

    Report Number
    23435584
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    September 23, 2025
    Report Date
    October 9, 2025
    Manufacturer
    INARI MEDICAL INC
    Product Code
    DXE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS BROUGHT TO IR [INTERVENTIONAL RADIOLOGY] ON [REDACTED] FOR A DVT [DEEP VEIN THROMBOSIS] THROMBECTOMY. CT VENOGRAM FROM [REDACTED] DISPLAYED AN OBJECT THAT LOOKED LIKE A STENT IN THE LEFT POPLITEAL. HOWEVER, NO STENT WAS EVER PLACED. WHEN ON IR TABLE FOR THROMBECTOMY ON [REDACTED], FLUOROSCOPY BETTER DISPLAYED WHAT APPEARS TO BE THE FILTER END OF AN INARI THROMBECTOMY SHEATH THAT WAS USED IN THE PRIOR THROMBECTOMY IN [REDACTED] - TWO MONTHS EARLIER. DR. WAS UNABLE TO RETRIEVE ANY CLOT DURING THE [REDACTED] CASE BECAUSE OF THIS OBSTRUCTION, DESPITE TRYING NUMEROUS ACCESS SITES. DR. WAS THE IR MD WHO PERFORMED THE PRIOR THROMBECTOMY IN [REDACTED]: TWO MONTHS AGO, WITH INARI REP ASSISTING. INARI HAS BEEN CONTACTED, WILL MAKE THEM AWARE OF THE DETAILS OF THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1906359 CLOTTRIEVER SHEATH, 13 FR CATHETER, EMBOLECTOMY DXE INARI MEDICAL INC 50-101 25020132

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other