MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP; CATHETER, THROMBUS RETRIEVER

Catalog Number	ET309645
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The device was discarded; therefore, no further investigation can be performed.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.Impeded in microcatheter is a known potential issues associated with the use of the device.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
As reported by the field, this was a mechanical thrombectomy of the internal carotid artery (ica) for cerebral infarction.After the balloon guiding catheter was advance into the internal carotid artery, red68 reperfusion catheter and phenom27 microcatheter were advanced into the occluded area and crossed the lesion.When the embotrap iii 6.5 mm x 45 mm thrombus retriver (et309645, 24c158av) was delivered using the phenom27, the embotrap became stuck in the phenom27 and could not be delivered.The embotrap and phenom27 were retrieved.After that, the user replaced the phenom27 and embotrap with new ones.The embotrap was deployed in the occluded area and retrieved, and recanalization was achieved.Carotid artery stenting was performed in the stenotic are of the ica and the procedure was completed.There was no impact to the patient.A continuous flush was done.Other concomitant devices were optimo8fr flex guiding catheter, chikai14 guidewire, phenom microcatheter, red68 catheter.Additional event information received on 04-feb-2025 indicated that no passes were made.The embotrap could not delivered to the lesion.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional event information received on 17-feb-2025 indicated that the microcatheter nor the embotrap appear damaged.The insertion tool was securely placed in the hub of the microcatheter prior to attempting to advance the embotrap.The physician mentioned that the device got stuck at the hub or immediately after passing through the hub, it is not clear.There was no damage (i.E.Kink) identified on the microcatheter.The proximal segment of the embotrap showed signs of damage.There was a slight delay due to the device replacement and reinsertion.The delay was not clinically significant.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: EMBOTRAP
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): NEURAVI LTD.; block 3; ballybritt business park; galway H91 K 5YD; EI H91 K5YD
• Manufacturer (Section G): ADVANT MEDICAL; parkmore business park west; galway H91 P V0V; EI H91 PV0V
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21322446
• Report Number: 3011370111-2025-00009
• Device Sequence Number: 8485392
• Product Code: NRY
• UDI-Device Identifier: 10886704082859
• UDI-Public: (01)10886704082859(17)270313(10)24C158AV
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K211338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ET309645
• Device Lot Number: 24C158AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHIKAI¿ NEUROVASCULAR GUIDEWIRE (ASAHI INTECC).; OPTIMO FLEX® BALLOON CATHETER (TOKAI MEDICAL).; PHENOM¿ 27 MICROCATHETER (MEDTRONIC).; RED 68¿ REPERFUSION CATHETER (PENUMBRA).
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian