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

Catalog Number EXM-4002-0000

Device Problem Overheating of Device (1437)

Patient Problem Intraoperative Pain (2662)

Event Date 08/11/2022

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 clinical specialist reported an end user experienced an issue when using a 0.9mm auryon catheter.It was reported that during an atherectomy procedure, the patient began having pain.The physician stated the auryon catheter became hot to the touch distal to the tip.The device was removed and the procedure was completed with a different device.

Manufacturer Narrative

The catheter complaint sample was forwarded to eximo facility for evaluation.The customer's reported complaint that the physician stated the auryon catheter became hot to the touch distal to the tip cannot be confirmed as no irregularity or non-conformance was observed.It is possible that the catheter was lasing at the same location without advancing and without proper flushing and accordingly the tip may have been heated few degrees that shall not cause pain.In this case when the physician pulled out the catheter from the patient body the tip would have been cooled to not more than the patient blood temperature.No correction or corrective action is required as no manufacturing non-conformance was observed during sample evaluation.The patient's pain may be attributed to the gw being subintimal and catheter following the gw.The procedure was completed with a different device.The patient did not experience any adverse effects, or harm, or require medical intervention as a result of this incident.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.The complaint event was forwarded to the laser catheter manufacturer (eximo).Eximo performed a dhr review of the reported catheter lot number 66205.The review confirmed that the lot met all material, assembly, and performance specifications, e.G., no manufacturing non-conformance reports were issued.No manufacturing non-conformances were observed during the sample evaluation.Risk management review: fmea/risk assessment reference document: eximo system risk analysis, document number rsa0100, rev.28 [reference p017451, rev.E], index no.16 (auryon bent/breakage inside the vessel tract).Severity rating (from risk analysis): 2 - moderate.Probability occurrence rating (from risk analysis): 4 - probable (1.0 to 10.0%), [10,001-100,000 ppm].Actual ppm: 0.0039% [39.3 ppm] (1 occurrence for auryon catheter/patient, "hot to touch/pain" / (b)(4) units sold [last 15 months] per july 2022 complaint report and agile complaint search).This frequency includes the occurrence reported per complaint (b)(4).Probability occurrence rating (actual): 2 - remote (0.001 to 0.01%), [11-100 ppm].The actual probability occurrence rating is within the expected probability occurrence rating listed in the risk documentation.Labeling review: instructions for use (ifu0100) 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 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: CATHETER EXIMO ATHERECTOMY
• Type of Device: PERIPHERAL ATHERECTOMY CATHETER
• Manufacturer (Section D): EXIMO MEDICAL LTD.; 3 pekeris street; glens falls, ny 12801, 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: 15374507
• MDR Text Key: 305894855
• Report Number: 1319211-2022-10006
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EXM-4002-0000
• Device Lot Number: 66205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2022
• 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