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

Catalog Number	BG8795U
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section h3 - the device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.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.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
A healthcare professional reported that this was a mechanical thrombectomy of the middle cerebral artery, segment m1 to treat acute cerebral infarction.Attempted to advance the emboguard 87, 95 cm balloon catheter (product code: bg8795u, lot number: 10140061), but the aorta was looped.After advancing to the common carotid artery, removed the inner catheter, at that time the emboguard got kinked.Replaced the emboguard with a new one and advanced again.The new emboguard could be advanced without issue, and recanalization was achieved by one pass using a combined technique (a cereglide 71 and embotrap 5x37).The procedure was completed.There was no negative impact to the patient.A continuous flush was done.Other concomitant device was trak microcatheter.

• 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: 25163025
• Report Number: 3011370111-2026-00059
• Device Sequence Number: 20984114
• Product Code: QJP
• UDI-Device Identifier: 10886704082743
• UDI-Public: (01)10886704082743(11)250825(17)280223(10)10140061
• 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,Followup,Followup,Followup
• Report Date (Section B): 07/06/2026

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: BG8795U
• Device Lot Number: 10140061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Supplement Date Received by Manufacturer: 05/19/2026; 06/12/2026; 07/01/2026; 07/02/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 06/04/2026; 06/15/2026; 07/01/2026; 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2025
• 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
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian