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

Catalog Number EXM-4004-0000

Device Problem Material Puncture/Hole (1504)

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

Event Date 06/11/2021

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 vascular surgeon reported an issue with a 2.35mm eximo atherectomy catheter.During a procedure, the doctor was attempting to lase and aspirate a left sfa chronic total occlusion from a right common femoral access site.The patient's iliac bifurcation was normal and not considered acute.Using a 7 french terumo destination sheath, the physician advanced the sheath and catheter together, over the bifurcation, and down to the sfa chronic total occlusion.When starting the lasing process, the catheter began to aspirate; however, part of the way through, the bubbles and liquid in the tubing appeared to stop.The physician continued to advance the catheter, continuing the atherectomy run, to the end of the occlusion in the sfa which was close to the adductor canal.The physician stopped the atherectomy procedure and the technologist removed the catheter to flush the aspiration lumen.There appeared to be a hole, where saline was leaking between 30-40cm and the distal tip of the catheter, as well as a possible kink.There was no light/energy observed from this perforation, only saline flush drops.The physician opted to set aside the 2.35mm catheter and continue the procedure with a new 2mm catheter, with the rounded tip.The procedure was completed successfully with the 2mm catheter and the physician was satisfied with the outcome.The patient did well and had good pulses after the procedure.It was indicated the reported device is available for return to the manufacturer for a device evaluation.

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint of catheter had hole that leaked saline cannot be confirmed since the complaint device was not returned for evaluation.Without receiving a catheter sample for evaluation, a definitive root cause for this event could not be determined.Potential root cause is handling damage to the catheter during use.A review of the distribution records was performed for the reported catheter serial number (b)(6) 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 serial number (b)(6).The review confirmed that the catheter met all material, assembly and performance specifications, e.G.No manufacturing non-conformance reports were issued.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.- 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: 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.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.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.Ask the laser operator to raise the fluence to the 60mj/mm2.Activate the laser and try again to advance the auryon catheter through the lesion.If the auryon catheter cannot be advanced, resume the self-count-down to 10 seconds.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; glens falls, ny 12801, rehovot 76702 03; IS 7670203
• MDR Report Key: 12179637
• MDR Text Key: 261936496
• Report Number: 1319211-2021-10013
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2022
• Device Catalogue Number: EXM-4004-0000
• Device Lot Number: 39754CJ85
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1