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

Catalog Number EXM-4001-0000

Device Problem Melted (1385)

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

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.(b)(4).

Event Description

A physician reported an issue with a 1.5mm eximo atherectomy catheter.A raebe 6f sheath and command es wire were used for the procedure.The lesion type was an sfa/pop isr cto, (types - isr/cto/highly calcified/long/tortuous/eccentric/ thrombus),40cm in length.The energy used was: 50mj- 3:57 minutes, 60mj- 2:12 minutes.When removing/withdrawing the auryon catheter, the command es wire was welded (burnt/melted) to the catheter.Dr.(b)(6) had to remove both 1.5 catheter and the wire together from the patient.The patient was treated using a balloon procedure.It was reported the catheter had been activated tlt: 6.04.No patient complications occurred.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.

Manufacturer Narrative

Returned for evaluation was a.5mm auryon catheter.The catheter complaint sample was forwarded to the eximo facility for evaluation.The catheter arrived and presented with a condition expected per event description; guidewire was returned inside the catheter.The guidewire was not melted or burnt to the catheter but a kink was located in the guidewire near the catheter's handle.The guidewire was pulled out manually with force.The catheter was also noted to have almost no active fibers at the tip.The failure mechanism is inconclusive as it is unknown - if a kink prevented the catheter from advancing and thus the catheter lased in the same spot for more than 10sec (not as in the ifu), or, the fibers had degraded during the long lesion activation and once not active, pushing the catheter in attempt to proceed created the kink in the guidewire.The rfid tag of the 1.5mm catheter was read and the catheter working time was 237sec at 50mj/mm2 and 132sec at 60mj/mm2; total time of 6:09 minutes.No manufacturing non-conformances were observed during catheter sample evaluation.The customer's reported complaint description of guidewire was welded (melted/burnt) to the 1.5mm catheter was not confirmed, however, the guidewire was stuck inside if the catheter due to a kink in the guidewire.The root cause of the guidewire kink could not be definitively determined.Potential contributing factors could be guidewire kink prevented the catheter from advancing and thus the catheter lased in the same spot for more than 10sec (not as in the ifu), or, the fibers had degraded during the long lesion activation and once not active, pushing the catheter in attempt to proceed created the kink in the guidewire.A review of the distribution records was performed for the reported catheter serial number (b)(6) for any deviations related to the reported defect 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: 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.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: 11797042
• MDR Text Key: 249728855
• Report Number: 1319211-2021-10007
• 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: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2022
• Device Catalogue Number: EXM-4001-0000
• Device Lot Number: 43503DN22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1