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

Catalog Number	BG8785U
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's reference number: (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.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 the procedure was a mechanical thrombectomy of the middle cerebral artery for treatment of an acute ischemic stroke, the lesion was tandem.The emboguard 87, 85 cm balloon catheter (bg8785u, 9840112) preparation was completed and inserted into the sheath.Because this was a tandem case, the emboguard was retained in the common carotid artery (cca) to continue the procedure.The emboguard kinked during withdrawal of the inner device, so it was replaced with an optimo.The procedure was successfully completed.There was no negative impact to the patient.A continuous flush was done.The devices were used according to the instructions for use (ifu).
Additional Manufacturer Narrative
Manufacturer ref# (b)(4) updated sections on this medwatch: b4, b5, g3, g6, h2, h6 and h11.Section b5: additional event information received on 12-nov-2025 indicating that there was no allegation of patient injury due to an alleged product issue.Complaint conclusion: a healthcare professional reported that the procedure was a mechanical thrombectomy of the middle cerebral artery for treatment of an acute ischemic stroke, the lesion was tandem.The emboguard 87, 85 cm balloon catheter (bg8785u, 9840112) preparation was completed and inserted into the sheath.Because this was a tandem case, the emboguard was retained in the common carotid artery (cca) to continue the procedure.The emboguard kinked during withdrawal of the inner device, so it was replaced with an optimo.The procedure was success sfully completed.There was no negative impact to the patient.A continuous flush was done.The devices were used according to the instructions for use (ifu).Additional event information received on 12-nov-2025 indicating that there was no allegation of patient injury due to an alleged product issue.Since no device has been received for analysis, no product investigation can be performed and the reported failure could not be evaluated.A device history review (dhr) associated with this lot 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.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4) updated sections on this medwatch: b4, b5, g3, g6, h2, and h11.Section b5: additional event information received on 04-dec-2025 indicated that although it is unclear if excessive force was used with the involved device, the senior physician commented that the possibility that excessive pushing force was applied cannot be ruled out.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: 23512877
• Report Number: 3011370111-2025-00115
• Device Sequence Number: 13167281
• Product Code: QJP
• UDI-Device Identifier: 10886704082736
• UDI-Public: (01)10886704082736(11)250429(17)271028(10)9840112
• 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
• Report Date (Section B): 12/02/2025

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: 9840112
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 12/04/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/01/2025; 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2025
• 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: Unknown