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

Catalog Number EXM-4001-0000

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/30/2021

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

An angiodynamics executive district sales manager reported an issue with a 1.5mm eximo atherectomy catheter during a lle revascularization procedure.A terumo destination 6f 45cm sheath and asahi mongo es 014 x 300cm wire were being used with the catheter to treat a mildly diseased lesion located in the sfa approximately 100mm.There was no tortuousity.The first catheter had been used at 60mj/mm2 for 5:23 minutes, with no difficulties advancing over the wire.The 1.5mm auryon catheter withdrawn as the time allowed was used up, and a second 1.5mm catheter was placed to complete the procedure.As the new catheter was being advanced, it was noted via imaging that the platinum tip of the first catheter had detached and was being pushed distally by the new catheter.The detached tip was located in the sfa, the clinician was able to retrieve the tip using a pta balloon.The procedure completed with another pta balloon, (not the one he used to remove the tip).The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.It was indicated the reported device is available for return to the manufacturer for a device evaluation.

Manufacturer Narrative

Returned for evaluation was an auryon1.5mm catheter.The 1.5mm catheter device arrived with no inner or outer blade (stainless steel tubes) as detailed in event description.This is a 68x100um 1.5mm catheter.No manufacturing non-conformances were observed during sample evaluation.The rfid tag of the 1.5mm catheter was read and the catheter working time was 52sec at 50mj/mm2 and 270sec at 60mj/mm2.The catheter had worked for a long period of time at 60mj/mm2, which can make the catheter fibers more prone to degradation.The customer's reported complaint description of catheter tip detached was confirmed.Althought the complaint description is confirmed, a definitive root cause cannot be determined.The most likely root cause of tip detachment is degradation of fibers at the tip.The root cause of the degradation of fibers cannot be definitively determined, however, potential root cause for this type of tip detached failure mode is catheter was working for an extended period of time at excessive energy, which is contrary to the ifu.Ifu cautions against lasing at the same location for more than 10 seconds, i.E.With no catheter advancement.A review of the distribution records was performed for the reported catheter lot number 46173 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.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).Correction to section b: initial mdr had both product problem and asverse event selected.Only product problem should be selected.

• 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: 11826008
• MDR Text Key: 251216127
• Report Number: 1319211-2021-10009
• 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: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2023
• Device Catalogue Number: EXM-4001-0000
• Device Lot Number: 46173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Date Manufacturer Received: 09/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR