MAUDE Adverse Event Report: NEURAVI LTD. EMBOGUARD; CATHETER, PERCUTANEOUS, NEUROVASCULATURE

Catalog Number	BG8785U
Medical Device Problem Codes	Material Twisted/Bent (2981); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that this was a mechanical thrombectomy of the middle cerebral artery m1p to treat acute ischemic stroke by a direct aspiration first-pass technique (adapt) using react71 catheter.The devices were used as per the instructions for use (ifu).The emboguard 87, 85 cm balloon guide catheter ((b)(6), (b)(6)) was advanced with the 6fr angiographic catheter and 35 guidewires, which was placed on pre petrous.When the angiographic catheter and guidewire were removed from the patient¿s body, the emboguard gradually slipped down.When the aspiration catheter react was advanced, the emboguard slipped to a position where it could no longer be visualized under expanded view.Adapt technique was performed using the react.When the react was removed from the patient¿s body, the fluoroscopy revealed that the emboguard got kinked at the bending part of the aorta.The angiography was performed as it was, and recanalization was achieved.The procedure was completed.There was no patient injury reported.Additional event information was received on (b)(6) 2025 indicating that there was no negative impact on the patient.The device was removed from the patient without the need for additional intervention.I was not necessary to remove the concomitant devices with the complaint device.Additional event information received on (b)(6) 2025 reported that there was no calcification, and although there was some tortuosity, it was within the normal range and was not a particularly unusual type of cerebral infarction.During the first pass, due to the action-reaction force, the emboguard gradually slipped while guiding the aspiration catheter (react).After the first pass, at the time of catheter removal, the flexible portion from the catheter tip to 17 cm was located at the curvature of the aortic arch.It is presumed that the kink occurred because the axis/core within the emboguard was lost upon removal of the aspiration catheter.No excessive force was applied to the device.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.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.
Additional Manufacturer Narrative
Manufacturer ref#(b)(4) updated sections on this medwatch: b4, g3, g6, h2, h6 and h11.Complaint conclusion: a healthcare professional reported that this was a mechanical thrombectomy of the middle cerebral artery m1p to treat acute ischemic stroke by a direct aspiration first-pass technique (adapt) using react71 catheter.The devices were used as per the instructions for use (ifu).The emboguard 87, 85 cm balloon guide catheter (bg8785u, 9833512) was advanced with the 6fr angiographic catheter and 35 guidewire, which was placed on pre petrous.When the angiographic catheter and guidewire were removed from the patient¿s body, the emboguard gradually slipped down.When the aspiration catheter react was advanced, the emboguard slipped to a position where it could no longer be visualized under expanded view.Adapt technique was performed using the react.When the react was removed from the patient¿s body, the fluoroscopy revealed that the emboguard got kinked at the bending part of the aorta.The angiography was performed as it was, and recanalization was achieved.The procedure was completed.There was no patient injury reported.Additional event information was received on 31-jul-2025 indicating that there was no negative impact on the patient.The device was removed from the patient without the need for additional intervention.I was not necessary to remove the concomitant devices with the complaint device.Additional event information received on 05-aug-2025 reported that there was no calcification, and although there was some tortuosity, it was within the normal range and was not a particularly unusual type of cerebral infarction.During the first pass, due to the action-reaction force, the emboguard gradually slipped while guiding the aspiration catheter (react).After the first pass, at the time of catheter removal, the flexible portion from the catheter tip to 17 cm was located at the curvature of the aortic arch.It is presumed that the kink occurred because the axis/core within the emboguard was lost upon removal of the aspiration catheter.No excessive force was applied to the device.An analysis of the product could not be performed since a physical sample was not received for evaluation.A device history review (dhr) associated with lot 9833512 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 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.The instructions for use (ifu) of the emboguard devices cautions users against advancing or withdrawing the catheter or dilator against resistance without careful assessment of the cause of resistance using fluoroscopy.If cause cannot be determined, withdraw the catheter/dilator while exercising caution.Movement against resistance may result in damage to vessel or catheter/dilator, e.G.Kinking, or cause patient injury.Additionally, if the emboguard catheter becomes severely kinked, users are instructed to withdraw the entire system, (i.E.Emboguard catheter, intermediate catheter, guidewire, etc.).Use of a damaged device may result in vessel injury.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: EMBOGUARD
• Common Device Name: CATHETER, PERCUTANEOUS, NEUROVASCULATURE
• Manufacturer (Section D): NEURAVI LTD.; block 3; ballybritt business park; galway H91 K 5YD; EI H91 K5YD
• Manufacturer (Section G): LAKE REGION MEDICAL GALWAY; parkmore business park west; county galway H91 C K22; EI H91 CK22
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22741743
• Report Number: 3011370111-2025-00088
• Device Sequence Number: 17582614
• Product Code: QJP
• UDI-Device Identifier: 10886704082736
• UDI-Public: (01)10886704082736(11)250422(17)271021(10)9833512
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K212340
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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: BG8785U
• Device Lot Number: 9833512
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2025
• 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: REACT 71¿ INTERMEDIATE CATHETER (MEDTRONIC).
• Patient Sex: Female