BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOTTRIEVER XL CATHETER

    MDR report key: 23262528 · Received October 9, 2025

    Report

    Report Number
    3020347218-2025-00067
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    September 12, 2025
    Report Date
    October 9, 2025
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    PMA / PMN Number
    K242557
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INARI DEVICES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR EVALUATION. THE DEVICE IDENTIFIERS WERE NOT PROVIDED, THE LOT HISTORY RECORDS OF ALL POTENTIAL LOTS SHIPPED TO THE FACILITY WERE REVIEWED. THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A POTENTIAL QUALITY ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. THE CASE WAS REVIEWED BY INARI STRYKER MEDICAL AFFAIRS, WHO CONCLUDED THAT THE PATIENT'S INJURY WAS THE RESULT OF AN OVERFILLED COLLECTION BAG AND POTENTIAL USER ERROR (USE WITH TUMOR). THE DEVICE INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING WARNINGS/CONTRAINDICATIONS: NOT INDICATED FOR THE REMOVAL OF FIBROUS, FIRMLY ADHERENT, OR CALCIFIED MATERIAL. CONTRAINDICATED IN PATIENTS WITH SUSPECTED TUMOR THROMBUS. AVOID USING EXCESSIVE FORCE TO ADVANCE OR RETRACT AGAINST RESISTANCE. IF EXCESSIVE RESISTANCE IS ENCOUNTERED, RETRACT, AND COLLAPSE THE COLLECTION BAG AND 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).

    Description of Event or Problem · 0

    THE PATIENT WAS A 45-YEAR-OLD FEMALE WHO PRESENTED WITH BILATERAL LEG PAIN AND SWELLING WITH SOME MILD EXERTIONAL DYSPNEA. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED BILATERAL PULMONARY EMBOLISM (PE), A LARGE INFERIOR VENA CAVA (IVC) THROMBUS, AND LEFT ILIAC VEIN THROMBUS. THE PATIENT'S PE WAS DETERMINED TO BE INTERMEDIATE LOW RISK, SO THE FOCUS WAS ON THE IVC AND LEFT ILIAC VEIN. THE PLAN WAS TO USE THE CLOTTRIEVER XL CATHETER (CTXL) FROM THE RIGHT COMMON FEMORAL VEIN (CFV) ACCESS AND TO DEPLOY THAT ABOVE THE TARGET IVC THROMBUS. A CLOTTRIEVER BOLD CATHETER (CT BOLD) WOULD BE UTILIZED FROM THE LEFT CFV ACCESS TO CLEAR THE ILIAC VEIN AND DEBULK THE IVC THROMBUS TO NOT OVERWHELM THE CTXL BASKET. WIRE AND CATHETER POSITIONING WAS OBTAINED WITHOUT ISSUE. THE CT BOLD WAS THEN USED TO PERFORM 4 PASSES WHILE INSIDE THE CTXL. THIS REMOVED SOME MIXED CHRONICITY CLOT AND RESTORED SOME PERFUSION IN THE COLLATERALS. CLOT REMAINED IN THE IVC THAT THE CT BOLD WAS UNABLE TO REMOVE. THE DECISION WAS MADE TO DO A GENTLE PASS WITH CTXL FROM ITS IVC LOCATION. MODERATE FORCE WAS REQUIRED BUT A FEW PIECES OF THROMBUS WERE REMOVED. THE THROMBUS WAS NOTED TO HAVE "AN ELEMENT OF A FATTY GELATINOUS TEXTURE". ANOTHER PASS WAS PERFORMED WITH THE CTXL WHEN THE COLLECTION BASKET BECAME OVERFILLED AND UNABLE TO BE RETURNED COMPLETELY INTO THE SHEATH. AFTER SEVERAL ATTEMPTS TO ADDRESS THE PROBLEM, THE DECISION WAS MADE TO PERFORM A CUTDOWN. AN ABDOMINAL CUTDOWN WAS PERFORMED AND A SIZABLE TUMOR WAS DISCOVERED ABOVE THE PELVIS AND IVC CONFLUENCE THAT WAS COMPROMISING TISSUE INTEGRITY. A GROIN CUTDOWN WAS COMPLETED TO REMOVE THE PROXIMAL PART OF THE SHEATH AND THE CATHETER THAT WAS EXTENDING OUT OF THE ACCESS SITE. THE BASKET AND ITS CONTENTS WERE LEFT IN THE PATIENT AS THE PHYSICIAN FELT AS IF IT WAS ACTING AS A TAMPONADE TO THE COMPROMISED RIGHT COMMON ILIAC VEIN THAT MAY HAVE RUPTURED DURING REMOVAL ATTEMPTS. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE AND WAS ADMITTED TO THE HOSPITAL SERVICE TO DO COMPLETE A WORKUP OF HER TUMOR. A FOLLOW-UP ON THE PATIENT REVEALED THAT THEY ARE CURRENTLY ALIVE AND THEIR CARE IS PRIORITIZING CANCER TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2217743 CLOTTRIEVER XL CATHETER PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 41-102

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Hospitalization| R| O CLOTTRIEVER SHEATH, 16 FR