MAUDE Adverse Event Report: EXIMO MEDICAL LTD. CATHETER EXIMO ATHERECTOMY; PERIPHERAL ATHERECTOMY CATHETER

Catalog Number EXM-4004-H000

Device Problems Fracture (1260); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2023

Event Type  malfunction  

Manufacturer Narrative

The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

A territory manager reported an end user experienced an issue when using two auryon atherectomy catheter 2.35mm - hydrophilic coated.The customer reported that both catheters had holes in them when they removed them.The customer stated that this issue caused problems with aspiration.No further information was provided.Reference (b)(4) for each device.(b)(6) 2023 additional information from gfe#1: i was not present at the start of this procedure.I do not have any pictures, but it is my understanding that the holes are near the tip of the catheters.Seeing as both catheters had the same issue, i asked the tech at the facility if it was possible that they damaged the catheters against the struts of the stent that they were treating or isr.He stated that this was a possibility, which makes more sense to me.Therefore the holes would have been created in the patient's body.

Manufacturer Narrative

The sample presented an expected appearance per the description.The customer's reported complaint description of that catheter had holes confirmed.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 damaged and causing holes in the catheter's shaft.The catheter was working for almost the maximally allowed duration at its highest energy of 60mj/mm2, which can also result in a higher fiber degradation rate and as a result the outer blade breaking.Additional optional root causes for damage to the outer blade can be attributed to the presence of a stent within the patient's body under the following circumstances: if the stent is fractured, it has the potential to inflict mechanical harm to the catheter.In situations where there are overlapping stents, a mechanical obstruction might arise, impeding the catheter's passage.In instances involving overlapping stents, the guidewire (gw) could guide the catheter to traverse between the two stents and not in their center.However, due to the stent's structure, this could lead to mechanical harm to the catheter.The factors mentioned above may contribute to mechanical blockage in the catheter, which causes the physician to apply excessive force, which in turn could result in catheter breakage.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.No manufacturing non-conformances were observed during the catheter sample evaluation.No correction or corrective action is required as no manufacturing non-conformance was observed during the sample evaluation.The dhr was reviewed for the reported 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 packaging lot number 80077 for any deviations related to the reported failure mode of the complaint.The review confirms that the lot met all packaging performance specifications, i.E., no ncr has been written.The complaint event was forwarded to the laser catheter manufacturer (eximo).Eximo performed a dhr review of the reported catheter lot number 80077.The review confirmed that the lot met all material, assembly, and performance specifications, e.G., no manufacturing non-conformance reports were issued.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.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", 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 wire.Advancement of auryon catheter through the lesion: a) do not to exceed 10 seconds of lasing at the same location.If you experience any difficulty to advance the auryon catheter, immediately start self-count-down.Self-count-down should start the moment you experience non-advancement of the auryon catheter.When advancement resumes, you should stop self-count-down and resume it if additional non-advancements are experienced.B) if the auryon catheter cannot be advanced by the 10th second of laser activation, you should release the foot switch 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 10 seconds count down.C) if the auryon catheter is still not advancing 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 self-count-down to 10 seconds.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).

• Brand Name: CATHETER EXIMO ATHERECTOMY
• Type of Device: PERIPHERAL ATHERECTOMY CATHETER
• Manufacturer (Section D): EXIMO MEDICAL LTD.; 3 pekeris street; building 2, suite 270; science park,, 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: 17350406
• MDR Text Key: 319296321
• Report Number: 1319211-2023-10007
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EXM-4004-H000
• Device Lot Number: 80077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male