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

Catalog Number EXM-4001-0000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/15/2022

Event Type  Injury  

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

An angiodynamics clinical specialist reported an issue with a 2mm eximo atherectomy catheter.A 6fr terumo precision antegrade sheath and a command wire were chosen and a 2mm catheter was selected due to isr and mixed plaque morphology.During the procedure, the catheter got to an eccentric calcified lesion and would not advance; therefore, the physician gave tension on the wire, from the retrograde sheath, but the device still would not advance.The device was removed and the inner blade and wire port were found to be detached from the catheter.A new 2.0 catheter was then reinserted and the case was finished.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The catheter used during this procedure was not returned for evaluation since there was no report of catheter or laser system malfunction, just anticipated procedural complication of thrombus.The customer's reported complaint of patient developed thrombus during the procedure cannot be confirmed given the nature of this serious adverse event.There was no report of catheter or laser system malfunction.Thrombus is cautioned in the instructions for use as a potential procedural complication.The lot/serial number of the catheter used in the procedure was not reported by the customer.A ship history report (shr) for the customer was performed to determine the three (3) most recent catheter lots shipped within six (6) months of the procedure date; the lot/serial numbers are (b)(6).A review of the distribution records was performed for the shr packaging lots indicated for any deviations related to the reported failure mode of the complaint.The review confirms that the lot(s) met all packaging performance specifications, i.E.No ncr written.The complaint event was forwarded to the laser catheter manufacturer (eximo).Eximo performed a dhr (device history records) review of the indicated catheter lots.The review confirmed that the lot(s) met all material, assembly, and performance specifications, e.G., no manufacturing non-conformance reports associated with the reported failure mode.Similar complaint trend review: there have been no previously reported complaints for the indicated catheter serial number for similar failure mode.An agile complaint search for the atherectomy disposables (catheter) product family for the failure mode (occurrences) "patient, thrombosis/embolism": june - 0, july - 0, and august - 1.This does not constitute an adverse trend.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, "thrombosis/embolism" / 25,473units 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: the procedural complication of thrombus and distal embolization is cautioned in the instructions for use (ifu0100) that is provided with the catheter device.In addition the ifu contains 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.The serial number of the hardware unit used during this event was not reported by the complainant.A review of the hardware service order records cannot be performed.In addition, the laser system could not contribute to the reported thrombus event.Based on no adverse trend, no issues observed during dhr review and process controls in place, no corrective action to be taken by angiodynamics at this time.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: 15374545
• MDR Text Key: 299450702
• Report Number: 1319211-2022-10007
• 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: 09/15/2022

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-4001-0000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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