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

Catalog Number	ET007533
Medical Device Problem Codes	Failure to Advance (2524); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a mechanical thrombectomy, an embotrap ii 5x33 revascularization device (et007533, 24d167av) impeded in introducer and could not be pushed into the microcatheter (mc).The doctor only retracted the stent alone and observed delivery wire of the stent was kinked/bent.A new device was switched to complete the surgery.The wellpath 0.021 microcatheter was not replaced.There was no patient injury reported.Additional event information received on 07-jan-2025 indicated that the event did not result in any undue procedural delay that could be considered clinically significant.There was no break in material integrity at the site of the defect, such as cracking or fracture.There was nothing noted to be obstructing the microcatheter.Based on the product analysis of the device received, the proximal collar was found damaged.
Additional Manufacturer Narrative
Product complaint (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The proximal collar was found damaged, the findings meet regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1.Initial reporter phone:(b)(6).Review of the provided photographs showed evidence of kinking of the embotrap ii device.It was not possible from the provided pictures to identify where the device had been kinked.While the complaint event has been confirmed the root cause of the event could not be determined from the provided pictures.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.The examination under magnification of the returned embotrap device showed evidence of deformation on the proximal struts of the returned device.Foreign matter was seen on the distal tip of the device.No further damage was seen on the device.The visual inspection indicates that the returned embotrap device was correctly assembled and manufactured, with all adhesive bonds and joints complete and undamaged.The returned embotrap device was successfully passed through a 0.0195¿ id tube, confirming that the profile conformed to the specification for compatibility with 0.021¿ microcatheters.It was not stated in the complaint event what microcatheter was used in the procedure.As per embotrap ii ifu cs030, ¿the device should be introduced through microcatheters indicated for the delivery of therapeutic devices in the neurovasculature of a size ¿18¿ or larger, with a minimum internal diameter of 0.021¿.¿ device insertion and delivery assessments were performed using the returned embotrap device and a sample compatible headway 21 microcatheter.The returned embotrap device was unable to be fully inserted into the sample headway 21 microcatheter and delivered to the distal tip.The complaint event was therefore confirmed.In attempt to recreate the reported event, device insertion and delivery assessments were also performed using a sample embotrap device and a sample compatible headway 21 microcatheter.These assessments demonstrated that failure to seat and secure the insertion tool correctly can result in failure to deliver the device through the headway 21 microcatheter hub.However, the root cause for this complaint could not be confirmed with the information provided.There is no indication that this complaint was a result of a defect or malfunction of the embotrap device.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.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: 21355936
• Report Number: 3011370111-2025-00012
• Device Sequence Number: 15691015
• Product Code: NRY
• UDI-Device Identifier: 10886704081326
• UDI-Public: (01)10886704081326(17)270418(10)ET007533
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K173452
• 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): 02/11/2025

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: ET007533
• Device Lot Number: 24D167AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2024
• 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: WELLPATH 0.021 MICROCATHETER
• Patient Sex: Unknown