MAUDE Adverse Event Report: Neuravi Ltd. EMBOGUARD; Catheter, Percutaneous, Neurovasculature

Catalog Number	BG8795U
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during treatment to a cerebral aneurysm an emboguard 87, 95 cm balloon guide catheter (product code: bg8795u, lot number: 10449662) was placed in the internal carotid artery, and upon inflation of the balloon, the balloon was found to have ruptured.The balloon was inflated to facilitate advancement of the emboguard distally, but due to the balloon rupture, the procedure was continued with the emboguard remaining at the internal carotid artery.The procedure was completed successfully without further issues.The devices were used according to the instructions for use (ifu).There was no negative impact to the patient.A continuous flush was done.The lesion was internal carotid artery.Other concomitant devices were exselsior sl 10 microcatheter.Additional event information received on 28-aug-2026 and 31-aug-2026 confirmed that there was no allegation of patient injury due to an alleged product issue.No balloon fragments were observed.According to the physician, the balloon did not rupture due to overinflation; rather, it is possible that the balloon had developed a tear at some point, which prevented it from being inflated.Final angiography performed at the end of the procedure showed no abnormalities.No remaining balloon fragments were identified in the patient¿s body.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4) information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section 8.Manufacturer report number: k212340;k233924 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 10449662 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.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 internal 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.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: 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: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50752987
• Report Number: 3011370111-2026-00110
• Device Sequence Number: 9414794
• Product Code: QJP
• UDI-Device Identifier: 10886704082743
• UDI-Public: (01)10886704082743(17)280705(10)10449662
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K212340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: 10449662
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2026
• 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