BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVCORE THROMBECTOMY CATHETER, 6-20MM, 12FR, 80CM

    MDR report key: 23619198 · Received November 21, 2025

    Report

    Report Number
    3020347218-2025-00081
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    October 23, 2025
    Report Date
    December 16, 2025
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVCORE THROMBECTOMY CATHETER (REVCORE) WAS RETURNED TO THE MANUFACTURER AND EVALUATED. VISUAL INSPECTION CONFIRMED THE REVCORE DISTAL TIP HAD SEPARATED FROM THE CATHETER. THE TIP AND CATHETER WERE OBSERVED UNDER MICROSCOPIC IMAGING, WHICH REVEALED CURED ADHESIVES ON BOTH MATING SURFACES. AS CURED ADHESIVE WAS OBSERVED, THE FAILURE IS UNLIKELY THE RESULT OF DEFICIENCIES IN THE MANUFACTURING PROCESS. THE DEVICE IDENTIFIERS WERE PROVIDED, AND THE LOT HISTORY RECORDS WERE REVIEWED. THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. ADDITIONALLY, A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND NO SIMILAR ISSUES HAVE BEEN REPORTED AGAINST THIS LOT NUMBER. THE TIP SEPARATED AT THE CUSTOMER'S SITE LIKELY DUE TO EXCESSIVE FORCE APPLIED TO THE DEVICE WHILE THE DEVICE WAS LIKELY CAUGHT IN PARTICULARLY TORTUROUS ANATOMY. THE DEVICE LABELING INCLUDES THE FOLLOWING WARNING: "AVOID USING EXCESSIVE FORCE TO ADVANCE OR RETRACT AGAINST RESISTANCE. IF EXCESSIVE RESISTANCE IS ENCOUNTERED, RETRACT, AND COLLAPSE THE CORING ELEMENT INTO THE OUTER CATHETER AND REMOVE THE DEVICE. EXCESSIVE FORCE AGAINST RESISTANCE MAY RESULT IN DAMAGE TO THE DEVICE OR VESSEL." THE MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS IN TRANSIT TO THE MANUFACTURER. UPON RECEIPT OF THE DEVICE A FULL EVALUATION WILL BE COMPLETED. MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2025, A 54-YEAR-OLD MALE PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. DURING THE THROMBECTOMY, THE RADIOPAQUE TIP OF THE REVCORE THROMBECTOMY CATHETER (REVCORE) DETACHED FROM THE CATHETER. THE RADIOPAQUE TIP REMAINED ON THE GUIDEWIRE AND WAS ABLE TO BE SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A 54-YEAR-OLD MALE PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. DURING THE THROMBECTOMY, THE RADIOPAQUE TIP OF THE REVCORE THROMBECTOMY CATHETER (REVCORE) DETACHED FROM THE CATHETER. THE RADIOPAQUE TIP REMAINED ON THE GUIDEWIRE AND WAS ABLE TO BE SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2024234 REVCORE THROMBECTOMY CATHETER, 6-20MM, 12FR, 80CM PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 44-101 24020117 00850291007383

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male