BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOTTRIEVER SHEATH, 16 FR

    MDR report key: 23538441 · Received November 12, 2025

    Report

    Report Number
    3020347218-2025-00076
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 12, 2025
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007123
    PMA / PMN Number
    K233815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLOTTREIVER SHEATH, 16FR (CT SHEATH) WAS RETURNED TO THE MANUFACTURER AND INVESTIGATED. VISUAL INSPECTION REVEALED TISSUE COVERING THE FUNNEL. THE TISSUE WAS REMOVED FROM THE DEVICE AND NO SIGNS OF DAMAGE OR DEFECTS WERE OBSERVED ON THE SHEATH SHAFT OR FUNNEL. THE PATIENT'S VESSEL DAMAGE WAS LIKELY DUE TO EXCESSIVE FORCE USED TO ADVANCE/RETRACT THE DEVICE AGAINST RESISTANCE, POSSIBLY EXASPERATED BY PATIENT ANATOMY AND/OR NAVIGATING A TORTUROUS INSERTION PATHWAY. TWO LOTS WERE PROVIDED, THAT COULD BE THE LOT WITH THE FAILURE. BOTH LOT HISTORY RECORDS WERE REVIEWED. THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. ADDITIONALLY, A COMPLAINT HISTORY REVIEW WAS CONDUCTED FOR BOTH LOTS AND NO SIMILAR ISSUES HAVE BEEN REPORTED AGAINST EITHER LOT NUMBER. THE DEVICE LABELING INCLUDES THE FOLLOWING WARNING: "AVOID USING EXCESSIVE FORCE TO ADVANCE OR RETRACT THE CLOTTRIEVER SHEATH AND DILATOR AGAINST RESISTANCE. IF EXCESSIVE RESISTANCE IS ENCOUNTERED, REMOVE THE DEVICE. EXCESSIVE FORCE AGAINST RESISTANCE MAY RESULT IN DAMAGE TO THE CLOTTRIEVER SHEATH AND DILATOR AND/OR VESSEL." THE DEVICE LABELING INCLUDES THE FOLLOWING PRECAUTION: "ULTRASOUND GUIDANCE SHOULD BE USED TO ENSURE DESIRED VESSEL TARGET AREA IS ACCESSED DURING INTRODUCER SHEATH PLACEMENT." VESSEL DISSECTION IS LISTED IN THE DEVICE LABELING AS A POSSIBLE ADVERSE EVENT/COMPLICATION. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2025, A FEMALE PATIENT UNDERWENT BILATERAL POPLITEAL DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD A PREEXISTING LEFT LOWER EXTREMITY STENT THAT HAD OCCLUDED. DURING THE PROCEDURE, THE LEFT POPLITEAL VEIN WAS ACCESSED WITHOUT ISSUE USING THE CLOTTREIVER SHEATH, 16FR (CT SHEATH) AND REVCORE CATHETER. UPON MOVING TO THE RIGHT POPLITEAL VEIN, ACCESS WAS ATTEMPTED BY INSERTING THE CT SHEATH. INITIAL ATTEMPTS ON THE RIGHT SIDE ENCOUNTERED A NETWORK OF COLLATERAL VEINS. TWO SEPARATE ATTEMPTS APPEARED TO HAVE ENTERED A COLLATERAL BASED ON WIRE TRAJECTORY AND VENOGRAPHY. INTRAVASCULAR ULTRASOUND (IVUS) WAS NOT USED TO CONFIRM THE LOCATION. THE PROCEDURE CONTINUED WITHOUT ANY APPARENT INTRAPROCEDURAL COMPLICATIONS. NO THROMBECTOMY WAS PERFORMED THROUGH THE RIGHT SIDE ACCESS, ONLY DEPLOYMENT OF THE FLOWTRIEVER XL CATHETER DISKS. UPON REMOVAL OF THE CT SHEATH, AT THE CONCLUSION OF THE PROCEDURE, TISSUE RESEMBLING VEIN WALL WAS ADHERENT TO THE SHEATH. THE PHYSICIAN STATED THAT THE VESSEL MAY HAVE EXTERNALIZED WITH THE SHEATH REMOVAL, AND THE PHYSICIAN EXCISED THE TISSUE. THE ACCESS SITE WAS CLOSED WITH SUTURES AND MANUAL PRESSURE WAS HELD. THERE WAS NO BLEEDING OR HEMATOMA IDENTIFIED AT THE TIME OF CLOSURE. UPON REVIEWING THE VENOGRAPHY POST-PROCEDURE, IT WAS DISCUSSED THAT THE ACCESS MAY HAVE BEEN IN A COLLATERAL VEIN. FOLLOW UP THE NEXT DAY POST-PROCEDURE, INDICATED THAT THE PATIENT WAS STABLE WITHOUT ANY REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946344 CLOTTRIEVER SHEATH, 16 FR PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 51-101 00850291007123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other FLOWTRIEVER XL CATHETER