BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVCORE THROMBECTOMY CATHETER

    MDR report key: 23380885 · Received October 24, 2025

    Report

    Report Number
    3020347218-2025-00072
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    September 27, 2025
    Report Date
    December 10, 2024
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    PMA / PMN Number
    K223609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 EXAMINATION OF THE REVCORE REVEALED STENT STRUT FRAGMENTS LODGED BETWEEN THE DISTAL END OF THE DEVICE CORING ELEMENT. NO DAMAGE OR DEFECTS WERE OBSERVED ON THE CORING ELEMENT OR OTHER COMPONENT OF THE DEVICE. THE DEVICE WAS FUNCTIONALLY TESTED BY OPENING AND CLOSING THE CORING ELEMENT. THE HANDLE KNOB EFFECTIVELY OPENED AND CLOSED THE CORING ELEMENT. AS NO ISSUES WITH THE DESIGN, MATERIALS, OR MANUFACTURING OF THE DEVICE WERE OBSERVED DURING THE INVESTIGATION, AND FULL FUNCTIONALITY WAS CONFIRMED, THE REVCORE LIKELY REMOVED PART OF THE PATIENT'S STENT AS A RESULT OF PROCEDURAL FACTORS; POTENTIALLY DUE TO THE PLACEMENT OF THE GUIDEWIRE THROUGH THE PATIENT'S STENT STRUTS OR USE WITH A DAMAGED OR FRACTURED STENT. 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 DEVICE LABELING INCLUDES THE FOLLOWING WARNING STATEMENTS: "BEFORE INSERTING THE CATHETER FOR USE IN PATIENTS WITH STENTS, ENSURE THE GUIDEWIRE IS PROPERLY PLACED, AND NOT THREADED OR ENTANGLED IN THE WIRE MESH OR LINING OF THE STENT." "WHEN REVCORE IS IN THE PATH OF AN EXPOSED STENT WITH BROKEN/FRACTURED STRUTS, A STENT 10MM IN DIAMETER, OR A STENT COMPRESSED TO 10MM, DAMAGE TO THE STENT, THE CORING ELEMENT, OR DISLODGMENT OF THE STENT, ETC. MAY OCCUR." "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." MANUFACTURER REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2025, A 55-YEAR-OLD MALE PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD A PREEXISTING STENT IN HIS INFERIOR VENA CAVA (IVC), EXTENDING INTO HIS LEFT COMMON ILIAC VEIN. THE STENT WAS COMPLETELY OCCLUDED WITH CLOT. WHILE REMOVING THE REVCORE THROMBECTOMY CATHETER (REVCORE), RESISTANCE WAS NOTED. UPON REMOVAL OF THE DEVICE, SMALL METAL STENT PIECES WERE FOUND WITHIN THE DEVICE. A PASS WAS COMPLETED USING THE CLOTTRIEVER BOLD AND MORE METAL STENT PIECES WERE RETRACTED. MORE PASSES WERE COMPLETED USING THE CLOTTRIEVER AND NO ADDITIONAL STENT FRAGMENTS WERE RECOVERED. THE FINAL VENOGRAM DID NOT SHOW ANY ISSUES WITH THE VESSEL OR STENT. THE PROCEDURE WAS COMPLETED WITHOUT ADDITIONAL ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403273 REVCORE THROMBECTOMY CATHETER PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 44-101 24100123

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male CLOTTRIEVER SHEATH, 16FR