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 Perforation of Vessels (2135)

Event Date 06/10/2021

Event Type  Injury  

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 sales manager reported a customer experienced an issue when using a 1.5mm auryon catheter yesterday ((b)(6) 2021).A galdius mongo es wire was used for the procedure.Dr.(b)(6) treated a long 20cm sfa lesion with a 1.5 catheter.It was lased on 50mj; 1:13 & 1:10 minutes, and 60mj for :43 seconds & 1:01 minutes, for a total lase time of 4:07 minutes.After treating, it was noticed a dissection.Ivus confirmed the dissection flap.He ballooned and stented with a saber 6.0x100 balloon post with a great end result in the sfa.The gladius mongo wire had also caused a perforation in the popliteal where the tip of the wire was placed.A viabahn stent was placed in the popliteal.He did not lase the popliteal.It was reported post procedure, the patient was doing well and the dissection resolved after placing stents.It was indicated that the reported device is not available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of patient vessel perforation could not be confirmed given the nature of this serious adverse event.In addition, no catheter sample was returned for evaluation.Per the event description, the likely root cause of the vessel perforation was the use of the guidewire during the procedure and not the advancement/use/lasing of the auryon catheter: "the gladius mongo wire had also caused a perforation in the popliteal where the tip of the wire was placed.A viabahn stent was placed in the popliteal.He did not lase the popliteal." in addition to the vessel perforation caused by the guidewire, there was also vessel dissection/patient injury reported during this procedure.The dissection was resolved after placing stents.A review of the distribution records was performed for the reported catheter lot number 47581 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 written.Complaint event was forwarded to laser catheter manufacturer (eximo).Eximo performed a dhr review of the reported catheter lot number 47581.The review confirmed that the catheter met all material, assembly and performance specifications, e.G.No manufacturing non-conformance reports were issue.Labeling review: 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.- 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.Potential complications: procedural complications: · 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.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
• MDR Report Key: 12100636
• MDR Text Key: 259433980
• Report Number: 1319211-2021-10012
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K181642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2023
• Device Catalogue Number: EXM-4001-0000
• Device Lot Number: 47581
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR