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)
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.The device was returned to j&j medtech for further evaluation.A non-sterile emboguard 87, 85 cm was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and multiple kinks were noticed along the entire length of the shaft of the emboguard catheter.Microscopic inspection revealed balloon shrinkage and a tear.A device history record (dhr) was performed, and no internal actions were identified.The issue reported regarding the kinked catheter is confirmed.While the complaint event was confirmed, the root cause was not determined.A potential cause of the kink on the returned device could be a tortuous patient anatomy; however, with the limited information reported, this remains speculative.There is no indication that this complaint was as a result of a defect or malfunction of the emboguard device.The balloon tear was not originally reported, and the exact time of occurrence cannot be determined; therefore, it is not considered related to the issue reported.As part of j&j medtech quality process all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no internal action is required.The instructions for use (ifu) provide the following warnings/precautions: ¿ do not torque the balloon guide catheter.This may result in damage to the device.Do not torque the dilator.This may result in damage to the device.Do not advance or withdraw 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.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.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 the distal body of an emboguard 87, 85 cm (product code: bg8785u, lot number: 9728701) was kinked when deployed carotid stent.No patient injury was reported.Additional event information received on 02-may-2026 indicated that the procedure was a combined carotid stenting (cas) and thrombectomy tandem case.The problem occurred at the cas case after the thrombectomy was completed.Recanalization had been achieved.No additional passes were planned when the damage occurred.The device/system had to be removed or replaced to continue the procedure.The event did not result in any undue procedural delay that could be considered clinically significant.The event did not result in patient harm.This was not a direct aspiration first pass technique case.The target vessel/site being treated was the common carotid artery (cca).There was no break in material integrity at the site of the defect, such as cracking or fracture.

• 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: 25175278
• Report Number: 3011370111-2026-00060
• Device Sequence Number: 10567308
• Product Code: QJP
• UDI-Device Identifier: 10886704082736
• UDI-Public: (01)10886704082736(11)250325(17)270923(10)9728701
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 05/14/2026

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: BG8785U
• Device Lot Number: 9728701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2025
• 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: Unknown