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

Catalog Number EXM-4003-0000

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

Patient Problem Perforation of Vessels (2135)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that the disposable 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 an issue with a 2mm eximo atherectomy catheter.During a case, the doctor planned to treat the sfa and peroneal.The doctor opted to use a 2.0 catheter.There were no issues using this catheter in the sfa; therefore, the doctor advanced into the peroneal.A 50mj pass from proximal to mid-peroneal was performed and the doctor opted to perform a 60mj pass.Once the catheter was removed from the patient, the doctor took a picture and it was evident that there was a perforation in the proximal peroneal.The doctor felt that there was at least one major perforation and some "micro" perforations above and below the obvious spot.The doctor then inflated a 3.0 balloon for 5 minutes in the lesion and also had a 3.5 covered stent on hand.Following the first balloon inflation, there was significant improvement; therefore, the doctor elected to inflate the balloon for another 5 minutes.After this balloon inflation was performed, there were no visible signs of perforation and the doctor decided that a covered stent was not necessary and believed that the patient was no longer at risk.It was indicated that the reported device is not available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

This medwatch is not to report a device malfunction, but to report an adverse patient effect during the procedure.There was no report of a device malfunction during the procedure.As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The catheter complaint sample was not returned for evaluation since there was no report of catheter or laser system malfunction during the procedure.The customer's reported complaint of catheter perforated the vessel was confirmed via x-ray images provided.There was no report of catheter or laser system malfunction during the procedure.Doctor was using the 2.0mm catheter in the sfa and peroneal.No issues using catheter in the sfa.Doctor advanced the catheter into the peroneal and performed pass from proximal to mid-peroneal at 50mj and then a pass at 60mj.Doctor stated that main perforation was in the proximal peroneal.Potential root cause for vessel perforation is size of catheter versus vessel size, i.E.Doctor decision to use 2.0mm catheter so low in the peroneal.This is supported by literature reporting as 2-3mm in external diameter of peroneal in patients with diseased vessel [https://core.Ac.Uk/download/pdf/268450645.Pdf] and a median of 3mm in large patients' groups [https://www.Ncbi.Nlm.Nih.Gov/pmc/articles/pmc6010244/ ].At retrospect, the fact that a 3mm balloon was used to manage the perforation supports that the inner diameter of the vessel was lesser than 3mmm, so a 2mm catheter is not recommended in this area and especially a second pass at 60mj.The lot/serial number of the catheter used was not reported by the end user, therefore, a ship history report (shr) was performed.The dhr review of the catheter s/n's from the shr confirmed that the catheters 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.- 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.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: 10731855
• MDR Text Key: 212996450
• Report Number: 1319211-2020-10011
• 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: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EXM-4003-0000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other