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

Catalog Number	ET307645
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a mechanical thrombectomy, an embotrap iii thrombus retriever 6.5 mm x 45 mm (et307645, 22e057av) pusher wire kinked.There was no patient injury reported.No additional information is available.Based on the analysis of the device received, the distal coil markers are damaged.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The distal coil marker was damaged, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial inspection and examination under magnification of the returned embotrap iii device showed evidence of damage and deformation to the shaft portion of the embotrap iii device.Slight deformation of the distal coil of the device was also observed.No other damage was observed on the returned device.The visual inspection also confirmed that the returned embotrap device was correctly assembled and manufactured, with all adhesive bonds complete and undamaged.It was reported that the ¿pusher wire¿ (device shaft) became kinked.No further information was provided in the event description.Visual inspection of the returned embotrap showed evidence of a severe kink at 423mm from the distal tip of the device.In addition, a slight kink was observed at 1305mm from the distal tip of the device.Although a full complaint recreation could not be performed based on the evidence provided in the event description, an attempt was made to recreate the ptfe flaking on a kink of a sample device.The recreation showed that a severe kink on a device may have caused the flaking of the ptfe.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.While the complaint event (kink on embotrap device) is confirmed, the root cause could not be determined.There is no indication that this complaint was as a result of a defect or malfunction of the embotrap device.Based on the limited information available for review, it is possible that procedural and handling factors may have contributed to the reported event.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.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.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.

• 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: 21172801
• Report Number: 3011370111-2025-00005
• Device Sequence Number: 17211740
• Product Code: NRY
• UDI-Device Identifier: 10886704082859
• UDI-Public: (01)10886704082859(17)250504(10)22E057AV
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 01/16/2025

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 Expiration Date: 05/04/2025
• Device Catalogue Number: ET307645
• Device Lot Number: 22E057AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2022
• 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
• Patient Sex: Unknown