MAUDE Adverse Event Report: EXIMO MEDICAL LTD. AURYON ATHERECTOMY CATHETER; CATHETER EXIMO ATHERECTOMY 2MM - HYDROPHILIC COATED

Model Number	EXM-4003-H000
Medical Device Problem Codes	Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported an end user experienced an issue when using an auryon atherectomy catheter 2.0mm - hydrophilic coated.It was reported that when inserting the catheter through a stent, something "is agreed upon" at the tip of the catheter.The procedure was completed with a new of the same device, and the patient was not harmed during the procedure.
Additional Manufacturer Narrative
The catheter was returned and inspected.The outer blade of the catheter arrived fractured and a piece was missing, the missing part is close to 15% of the total area of the blade, which based on the outer blade dimensions, would be between 2mm^2 and 2.8mm^2 in the area.The catheter arrived with almost no active fibers.3 kinks were observed along the catheter axis, 23cm, 43cm and 104 cm from its distal end.The catheter working time was 4:42 minutes at 50 mj/mm2 and 5:00 minutes at 60 mj/mm^2 (which is the maximum working time allowed at 60mj and close to the maximal total time of 10 minutes).There are several potential root causes - additional tension that the physician gives to the catheter may have resulted in excessive force and a higher fiber degradation rate that apparently can lead to the outer blade being fractured and causing kinks in the catheter's shaft.- the catheter was working for the maximally allowed duration at its highest energy of 60mj/mm^2 and almost the maximal time in 50mj/mm^2, which can also result in a higher fiber degradation rate and as a result the outer blade fracturing.- where the outer blade had mechanical damage, there is more possibility for mechanical damage to the fibers.- as the catheter passed through a stent, mechanical obstruction might arise, impeding the catheter's passage.The mechanical damage to the catheter could have been due to potential interaction between the catheter's blade and the stent's struts.If heparin/saline solution wasn't injected through the sheath during the procedure, the friction between the sheath and the catheter could've increased, resulting in excessive force that the physician has to apply, which causes a higher fiber degradation rate that apparently can lead to the outer blade fracturing.It is important to note that per image of the blade, the edges of the remaining blade in the breakage points are pointed out externally, in addition to the small broken part being released to the bloodstream, which may cause embolization.These risks are determined only theoretically, since in real life, nothing happened to the patient, no difficulties advancing were mentioned, and per the event description reported, the procedure was completed successfully with another catheter, and the patient was not harmed/injured.Before the procedure, the catheter was checked and found normal.The procedure was done under fluoroscopy, and the patient was unaffected.This is evidence that the blade part fell outside the patient's body, or was withdrawn together with the sheath, and the patient was not harmed during the procedure.A clinical review of the complaint event and additional follow-up with the end user was not required since the failure mode of this event is captured within the risk management review (fmea) for this device.The dhr was reviewed for the catheter lot number.The review confirmed that the lot met all material, assembly, and performance specifications, e.G., no manufacturing non-conformance reports were issued.A review of the distribution records was performed for the reported catheter serial number (b)(6) for any deviations related to the reported failure mode of the complaint.The review confirms that the catheter met all packaging performance specifications, i.E., no ncr has been written.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.A review of the angiodynamics complaints 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).

• Brand Name: AURYON ATHERECTOMY CATHETER
• Common Device Name: CATHETER EXIMO ATHERECTOMY 2MM - HYDROPHILIC COATED
• Manufacturer (Section D): EXIMO MEDICAL LTD.; 3 pekeris street; rehovot 76702 03; IS 7670203
• Manufacturer (Section G): EXIMO LTD.; 3 pekeris street; building 2, suite 270; science park, rehovot 76702 03; IS 7670203
• Manufacturer Contact: yoel zabar ; 3 pekeris street; building 2, suite 270; science park, rehovot 76702-03 ; IS 7670203
• MDR Report Key: 23582017
• Report Number: 1319211-2025-10014
• Device Sequence Number: 18488991
• Product Code: MCW
• UDI-Device Identifier: 07290017590165
• UDI-Public: 07290017590165
• Combination Product (Y/N): N
• Initial Reporter Country: WZ
• PMA/510(K) Number: K221077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/25/2026
• Device Model Number: EXM-4003-H000
• Device Lot Number: 00101590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown