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

Catalog Number	SBC92114UG
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during a thrombectomy procedure, the physician attempted to use a cereglide 92 intermediate catheter (product code: sbc92114ug, lot number: 31679920) it in a stroke procedure, however the device kinked inside the patient¿s body and the user was not able to advance anything.He ended up pulling it out and changing systems.There were no procedural delays due to the event.The procedure was successfully completed.Additional event information received on 08-may-2026 indicated that the target vessel was the left internal carotid artery (ica) and left m1 segment.There was no significant tortuosity or calcification.There was no allegation of patient injury due to an alleged product issue.The physician notes that this was a ica and m1 occlusion, the arch was a type two and a half, there was calcified atherosclerosis up in the intracranial ica but no significant disease at the bifurcation or in the cervical segment.The user advanced the catheter over six french sim 2 over a stiff glide wire so that the user could provide a good strong support base.However, when the user tried to advance inner catheter that comes with the cereglide, it kept getting stuck somewhere and looked down to see that this hair glide had kinked at the takeoff of the left common.The user was able to pull the catheter back to straighten the kink out but eventually had to change systems because it kept doing the same thing every time another pass was attempted.The innerglide was not advanced over a wire.A 9f merit short sheath, from the "dash" that comes in the stryker broadway aspiration kit was used.
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.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.

• Brand Name: CEREGLIDE
• Common Device Name: 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: 25161083
• Report Number: 3007628272-2026-00039
• Device Sequence Number: 10738213
• Product Code: QJP
• UDI-Device Identifier: 10886704086017
• UDI-Public: (01)10886704086017(17)280531(10)31679920
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2026

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: SBC92114UG
• Device Lot Number: 31679920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2026
• Supplement Date Received by Manufacturer: 06/11/2026; 06/18/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 06/18/2026; 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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