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

Catalog Number	BG8785U
Medical Device Problem Codes	Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that this was a mechanical thrombectomy by combined technique using esperance aspiration catheter and embotrap (product and lot unknow).During the advancement of an emboguard 87, 85 cm balloon guide catheter (bg8785u, 9833512) to the internal carotid artery, the emboguard got kinked.The emboguard was replaced with an optimo balloon guide catheter and the procedure was successfully completed.There was no negative impact on the patient.A continuous flush was done.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The company is seeking this information through the event investigation.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, b5, g3, g6, h2, h6 (medical device problem code) and h11.Section b5: additional event information received on 21-aug-2025 indicated that there was relatively severe tortuosity of the aortic arch, and the internal carotid artery had severe calcification that could have contributed to the kinking of the device.The emboguard was stuck at the ridge of ophthalmic artery.There was resistance prior to the event, and the physician felt a sensation of pushing through and coming out.There was not too excessive force used with the product, but a certain amount of force was applied.The physician commented that after replacing it, the optimo was able to advance without kinking when the same amount of force was applied.The target vessel/site was the internal carotid artery.There was no allegation of patient injury due to an alleged product issue.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, g3, g6, h2, h6 and h11.Complaint conclusion: a healthcare professional reported that this was a mechanical thrombectomy by combined technique using esperance aspiration catheter and embotrap (product and lot unknow).During the advancement of an emboguard 87, 85 cm balloon guide catheter (bg8785u, 9833512) to the internal carotid artery, the emboguard got kinked.The emboguard was replaced with an optimo balloon guide catheter and the procedure was successfully completed.There was no negative impact on the patient.A continuous flush was done.Additional event information received on 21-aug-2025 indicated that there was relatively severe tortuosity of the aortic arch, and the internal carotid artery had severe calcification that could have contributed to the kinking of the device.The emboguard was stuck at the ridge of ophthalmic artery.There was resistance prior to the event, and the physician felt a sensation of pushing through and coming out.There was not too excessive force used with the product, but a certain amount of force was applied.The physician commented that after replacing it, the optimo was able to advance without kinking when the same amount of force was applied.The target vessel/site was the internal carotid artery.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 complaints could not be confirmed.Based on the device history record review, there is no indication that the events are related to the device manufacturing process.The exact cause of the event could not be determined; however, it was noted that there was relatively severe tortuosity of the aortic arch, and the internal carotid artery had severe calcification that could have contributed to the kinking of the device.The instructions for use (ifu) of the emboguard devices caution 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: 22717129
• Report Number: 3011370111-2025-00086
• Device Sequence Number: 18424951
• 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,Followup
• Report Date (Section B): 09/08/2025

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: 07/17/2025
• Supplement Date Received by Manufacturer: 08/22/2025; 09/05/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 08/26/2025; 09/08/2025
• 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: EMBOTRAP; ESPERANCE¿ ASPIRATION CATHETER (WALLABY MEDICAL)
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 33 KG
• Patient Race: Asian