MAUDE Adverse Event Report: CERENOVUS, INC. CEREGLIDE; CATHETER, THROMBUS RETRIEVER CATHETER, PERCUTANEOUS, NEUROVASCULATURE

Catalog Number	NIC71132U
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that this was a mechanical thrombectomy, with a 132cm cereglide 71 catheter (nic71132u, 31347322).The physician completed first pass, removed and cleaned the cereglide and before re-inserting the catheter for a second pass noticed a ¿crimp¿ approx.10cm proximal to the distal tip of the catheter.He completed the procedure with a different catheter.There was no patient injury reported.Additional event information received on 25-aug-2025 indicated that the target vessel/site was an occlusion at the right middle cerebral artery (mca).It was further clarified that the catheter had a ¿flattened¿ kink about 10cms from distal tip.Normal anatomy was noted.The physician expected that it happened in the rhv.
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.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, g3, g6, h2, h3, h6 and h11.Complaint conclusion: a healthcare professional reported that this was a mechanical thrombectomy, with a 132cm cereglide 71 catheter (nic71132u, 31347322).The physician completed first pass, removed and cleaned the cereglide and before re-inserting the catheter for a second pass noticed a ¿crimp¿ approx.10cm proximal to the distal tip of the catheter.He completed the procedure with a different catheter.There was no patient injury reported.Additional event information received on 25-aug-2025 indicated that the target vessel/site was an occlusion at the right middle cerebral artery (mca).It was further clarified that the catheter had a ¿flattened¿ kink about 10cms from distal tip.Normal anatomy was noted.The physician expected that it happened in the rhv.Since no device has been received for analysis, no product investigation can be performed and the reported failure could not be evaluated.A manufacturing record evaluation was performed for the finished device 31347322 number, and no non-conformances related to the malfunction were identified.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing record evaluation, 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.Catheter kinking/damage during clinical use is a known and common occurrence occurring during angiography and is typically related to anatomy, technique, skill, and vessel tortuosity.The instructions for use cautions users to inspect for kinks and bends, or other signs of damage prior to and during use.Any product with damage is not to be used.If the operator encounters kinking or damage during use, they are clinically trained to immediately discontinue manipulations and remove the product.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: CEREGLIDE
• Common Device Name: CATHETER, THROMBUS RETRIEVER CATHETER, PERCUTANEOUS, NEUROVASCULATURE
• Manufacturer (Section D): CERENOVUS, INC.; 6303 waterford district drive; suites 215 & 315; miami FL 33126
• Manufacturer (Section G): CERENOVUS INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22954915
• Report Number: 3007628272-2025-00046
• Device Sequence Number: 12894266
• Product Code: NRY
• UDI-Device Identifier: 10886704085409
• UDI-Public: (01)10886704085409(17)270430(10)31347322
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K221934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

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: NIC71132U
• Device Lot Number: 31347322
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2024
• 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