BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER EXIMO ATHERECTOMY

    MDR report key: 23110094 · Received September 22, 2025

    Report

    Report Number
    1319211-2025-10009
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    August 25, 2025
    Report Date
    October 2, 2025
    Manufacturer
    EXIMO MEDICAL LTD.
    Product Code
    MCW
    PMA / PMN Number
    K230709
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORTED COMPLAINT OF A PATIENT ADVERSE EVENT - A THROMBUS - CANNOT BE CONFIRMED, GIVEN THE NATURE OF THE PATIENT-FOCUSED EVENT. THERE WAS NO REPORTED MALFUNCTION OF THE AURYON CATHETER OR LASER SYSTEM DURING THE EVENT. THIS IS CAUTIONED IN THE IFU AS AN ANTICIPATED POTENTIAL PROCEDURAL COMPLICATION. BEFORE AND ALSO AFTER THE PROCEDURE, THE CATHETER WAS CHECKED AND FOUND NORMAL (WITHOUT KINKS AND STRAIGHT). AFTER INVESTIGATING THE THROMBUS ISSUES FROM THE LAST CASES, THE REP FOUND DR. Z'S TECHNIQUE WAS TOO FAST, POSSIBLY CAUSING THE PROBLEMS. HE HAS SINCE SLOWED DOWN, AND NO ISSUES HAVE OCCURRED IN ABOUT 10 CASES. A THROMBUS APPEARED AFTER PROCEDURES, BUT IT'S UNCLEAR IF THE LASER OR THE BALLOON CAUSED IT, AND THE LASER GENERATOR IS FINE. THE THROMBUS WAS CLEARED WITH ASPIRATION, AND THE PATIENTS ARE FINE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE END USER DID NOT REPORT THE CATHETER'S LOT/SERIAL NUMBER, SO A SHIP HISTORY REPORT (SHR) WAS PERFORMED. THE DHR REVIEW OF THE CATHETER S/N FROM THE SHR CONFIRMED THAT THE CATHETER MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS, E.G., NO MANUFACTURING NON-CONFORMANCE REPORTS WERE ISSUED. DURING THE UNIT EVALUATION, THE LASER SYSTEM EXL189 UNDERWENT A FUNCTIONAL TEST, FOLLOWING SVC-009-S10, AND AN ELECTRICAL SAFETY TEST ACCORDING TO SVC-027, WITH ALL TESTS PASSING WITHOUT ISSUE (REFERENCE (B)(4). THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION ABOUT A FEW THROMBUS EVENTS COULD NOT BE REPRODUCED. NO CORRECTION IS REQUIRED SINCE THERE WAS NO REPORT OF DEVICE MALFUNCTION DURING THE PROCEDURE, AND THE DISTAL EMBOLIZATION EVENT IS AN ANTICIPATED PROCEDURAL COMPLICATION THAT IS CAUTIONED IN THE IFU. LABELING REVIEW: INSTRUCTIONS FOR USE (IFU0110 / IFU0120) ARE PROVIDED WITH THE CATHETER DEVICE AND CONTAIN THE FOLLOWING STATEMENTS: WARNINGS PAY CAREFUL ATTENTION WHILE USING THE CATHETER, AVOID EXCESSIVE FORCE AND BE ON ALERT FOR ANY POTENTIAL DAMAGE. INADVERTENT MOVEMENT OF THE CATHETER MAY RESULT IN PATIENT INJURY. ALWAYS USE FLUOROSCOPIC SURVEILLANCE WHEN ADVANCING THE AURYON CATHETER INSIDE THE PATIENT VASCULATURE TO AVOID MISPLACEMENT, DISSECTION, OR PERFORATION. PROXIMAL VESSEL DIAMETER MUST BE [?]150% OF THE OUTER DIAMETER OF THE AURYON CATHETER. ALWAYS USE FLUOROSCOPIC SURVEILLANCE WHEN ADVANCING THE AURYON CATHETER INSIDE THE PATIENT VASCULATURE TO AVOID MISPLACEMENT, DISSECTION, OR PERFORATION. AURYON CATHETER INSERTION OVER THE WIRE UNTIL LASER ACTIVATION: YOU MAY USE ANY OTHER GW TO CROSS THE LESION, BUT THE FINAL GW THAT AURYON CATHETERS WILL TRACK OVER SHOULD BE 300CM 0.014" (FOR LONGER LENGTH (XL) CATHETERS, USE A PREFERRED 0.014'' GUIDE WIRE (GW) OF AN APPROPRIATE LENGTH; FOR 1.7MM CATHETERS, 0.018'' GW MAY BE USED), AND PREFERABLY STIFF GWS. ONCE THIS GW IS ANGIOGRAPHICALLY VERIFIED TO CROSS THE LESION IN THE VESSEL'S LUMEN, IT IS READY FOR AURYON CATHETER INSERTION OVER THE GUIDE WIRE. ADVANCEMENT OF AURYON CATHETER THROUGH THE LESION: A) DO NOT TO EXCEED 10 SECONDS OF CONTINUOUS LASING AT THE SAME LOCATION. IF YOU EXPERIENCE ANY DIFFICULTY ADVANCING THE AURYON CATHETER, IMMEDIATELY START A 10-SECONDS SELF-COUNT-DOWN. SELF-COUNT-DOWN SHOULD START THE MOMENT YOU EXPERIENCE NON-ADVANCEMENT OF THE AURYON CATHETER. WHEN ADVANCEMENT RESUMES, STOP THE SELF-COUNT-DOWN AND RESUME IT IF ADDITIONAL DIFFICULTY ADVANCING THE AURYON CATHETER IS EXPERIENCED. B) IF THE AURYON CATHETER CANNOT BE ADVANCED BY THE 10TH SECOND OF LASER ACTIVATION, RELEASE THE FOOTSWITCH TO STOP THE LASER, RETRACT THE CATHETER APPROXIMATELY 3-4 MM, AND TRY TO ADVANCE AGAIN WHILE ROTATING THE CATHETER SHAFT APPROXIMATELY 90 DEGREES TO EITHER SIDE, WHILE RESUMING THE 10-SECOND SELF-COUNT-DOWN. C) IF THE AURYON CATHETER STILL CANNOT BE ADVANCED WITH THE ABOVE-MENTIONED ROTATION MANIPULATION FOR THE ADDITIONAL 10-SECONDS, IMMEDIATELY STOP THE LASER ACTIVITY BY RELEASING THE FOOTSWITCH. D) ASK THE LASER OPERATOR TO RAISE THE FLUENCE TO THE 60MJ/MM2. E) ACTIVATE THE LASER AND TRY AGAIN TO ADVANCE THE AURYON CATHETER THROUGH THE LESION. F) IF THE AURYON CATHETER CANNOT BE ADVANCED, RESUME THE 10-SECOND SELF-COUNT-DOWN. G) IF THE AURYON CATHETER CANNOT BE ADVANCED IN THIS ATTEMPT, STOP THE LASER ACTIVITY, WITHDRAW THE AURYON CATHETER AND USE A NEW CATHETER. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION RESULTS WILL BE SENT ON A SUPPLEMENTAL REPORT. REFERENCE: (B)(4).

    Description of Event or Problem · 0

    AN ANGIODYNAMICS EXECUTIVE DISTRICT SALES MANAGER REPORTED THAT A THROMBUS WAS PRESET IN THE PATIENT, AFTER USE OF AN AURYON 1.5MM CATHETER AND BALLOON. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2070925 CATHETER EXIMO ATHERECTOMY PERIPHERAL ATHERECTOMY CATHETER, MCW EXIMO MEDICAL LTD. EXM-4001-H000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other