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

Catalog Number	NIC71137U
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.(b)(4).Information regarding patient identifier, date of birth, age, sex, gender, weight, race, and ethnicity were not provided.Section d.2b: procode is nry/qjp.Section h.3: 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.A review of manufacturing documentation associated with this lot (31684676) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no internal actions related to device manufacture or inspection.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.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 manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during a stroke procedure, the physician used a 132cm cereglide 71 intermediate catheter (nic71132u / 31668075) through a zoom¿88 aspiration catheter (imperative care).Both catheters were well-hydrated (flushed), the cereglide reportedly got stuck in the zoom 88.During the advancement of the cereglide 71 catheter, the physician reported that it felt tight and as a result, the physician removed it and the cereglide 71 catheter stretched.The physician tried the second cereglide, a 137 cm cereglide 71 catheter (nic71137u / 31684676).Everything flushed well but the same issue was encountered.There was no negative impact on the patient.Additional information was received on 04-may-2026.Per the information, the procedure was targeting the m1 segment of the left middle cerebral artery.The target vessel was not excessively tortuous.The second cereglide catheter was also used with the zoom 88.The information indicated that for both cereglide catheters, the issue occurred on the first pass.After the second cereglide catheter, the physician used a zoom 7mm x 137mm to complete the procedure.The zoom 88 was also used to complete the procedure.It was confirmed that the zoom 88 was used again with the zoom 7mm x 137mm to complete the procedure.

• 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 ; 949788-2078
• MDR Report Key: 25086331
• Report Number: 3007628272-2026-00036
• Device Sequence Number: 10537253
• Product Code: NRY
• UDI-Device Identifier: 10886704085386
• UDI-Public: (01)10886704085386(17)280531(10)31684676
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2026

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: NIC71137U
• Device Lot Number: 31684676
• 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: 04/25/2026
• Supplement Date Received by Manufacturer: 05/21/2026; 05/28/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 05/21/2026; 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• 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