MAUDE Adverse Event Report: EXIMO MEDICAL LTD. B-LASER ATHERECTOMY CATHETER 1.5 MM OTW; PERIPHERAL ATHERECTOMY CATHETER

Model Number EXM-4001-0000

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/23/2020

Event Type  Injury  

Manufacturer Narrative

The reported device has been returned to the manufacturer.The plant investigation is in process.Reference (b)(4).

Event Description

At the closure of an atherectomy procedure, it was noted an eximo 1.5 mm catheter blade had detached while inside of a patient.Attempts to remove the detached blade from within the patient were unsuccessful.The blade was not removed.The patient was reported as stable.The reported device has been returned to the manufacturer for evaluation.

Manufacturer Narrative

Returned for evaluation was an auryon catheter.The catheter was forwarded to angiodynamics' manufacturer of the product for evaluation and root cause determination.Per the evaluation, the customer's reported complaint description of tip detached is confirmed.The blade tip was detached from the end of the catheter and was not returned.The tip of the catheter shows an expected pattern of use for an extended period of time.The root cause is likely related to handling damage during use of the catheter, i.E.Lasing for an extended period of time.Instructions for use (ifu) cautions against lasing at the same location for more than 10 seconds, i.E.With no catheter advancement.A review of the device history record (dhr) for catheter lot: ex017ao78 was performed to determine if any deviations related to the reported defect of the complaint.The review confirmed that the lot met all material, assembly and performance specifications.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.Potential complications: distal embolization.Note: it is expected, especially with cto lesions at the cap, that the advancement rate may be slower.In any such case, and in any other occasion that the catheter does not seem to be advancing at a certain point, please follow the instructions below: 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.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.Complaint reference: (b)(4).

• Brand Name: B-LASER ATHERECTOMY CATHETER 1.5 MM OTW
• 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: 10052305
• MDR Text Key: 190803170
• Report Number: 1319211-2020-10005
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07290017590004
• UDI-Public: 07290017590004
• 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: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2022
• Device Model Number: EXM-4001-0000
• Device Catalogue Number: EXM40010000
• Device Lot Number: EX017AO78
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other