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

Catalog Number EXM-4001-0000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Respiratory Failure (2484)

Event Date 09/30/2021

Event Type  Death  

Manufacturer Narrative

It was reported that the device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

An angiodynamics executive district sales manager reported a patient issue during treatment with a 1.5mm eximo atherectomy laser catheter.During the procedure, the doctor treated a focal sfa and popliteal lesion with the catheter and then ballooned, with great results.At the end of the procedure, the patient coded.At this time, all devices were fully removed from the patient with zero complications from the eximo catheter or the balloon.The patient was revived and is currently stable and doing well.The doctor reported that the code was the result of an airway issue and had nothing to do with the eximo catheter or the balloon.The associated device used for the procedure is not available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Reference (b)(4).

Event Description

Additional information received by the end-user reported that the patient's coding event was caused by an airway issue and it was not related to the auryon device or the balloon as both devices were completely removed 45 minutes before the patient's coding event occurred.Additionally, the end-user reported that at an unknown time post-procedure, the patient expired.The patient's expiration was reported and presumed to not be related to the auryon treatment previously provided.Multiple good faith efforts were conducted to gather additional information related to the event, however response from the end-user facility stated refusal to provide any additional information related to event.As the date of the patient's expiration is unknown, this information is being reported in good faith.

Manufacturer Narrative

The product associated with this event was not returned for evaluation> as there was no report of an auryon catheter malfunction during the procedure, the end user had discarded the device.The auryon catheter was not inside of the patient at the time of the cardiac code and is not indicated to be a contributing factor to the serious adverse event.The customer's reported complaint description cannot be confirmed due to the nature of this patient serious adverse event; there were no reports of auryon catheter device malfunction during the procedure.No catheter sample was returned for evaluation.It was concluded that the auryon catheter usage was unrelated to the patient's cardiac issue/coding.The cardiac issue/coding was determined to be a result of an airway issue that occurred after the completion of the atherectomy procedure.A review of the distribution records was performed for the reported packaging lot number 51321 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 written.The omplaint event was forwarded to laser catheter manufacturer (eximo).Eximo performed a dhr review of the reported catheter lot number 51321.The review confirmed that the lot met all material, assembly and performance specifications, e.G.No manufacturing non-conformance reports were issued.Labeling review: the auryon catheter device was not returned for evaluation since there was no reported device malfunction during the procedure.It cannot be determine if device was used inconsistent with its labeling.Instructions for use is 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.Potential complications: procedural complications: · thrombus.· distal embolization.Serious adverse events: · death.· stroke.Other adverse events: · mi.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.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; 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: 12688073
• MDR Text Key: 278093755
• Report Number: 1319211-2021-10019
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2023
• Device Catalogue Number: EXM-4001-0000
• Device Lot Number: 51321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2020
• 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 Outcome(s): Life Threatening; Required Intervention; Death
• Patient Age: 70 YR
• Patient Sex: Male