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

Catalog Number	SBC92122UG
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2025
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.Section d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.Section h4: the device manufacture date is not known as the device lot number is not available / not reported.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.
Event or Problem Description
A healthcare professional reported that a during a mechanical thrombectomy, a cereglide 92 catheter (sbc92122ug, lot unknown) was being advanced to the middle cerebral artery (mca) during an ischemic stroke, the middle portion of the cereglide 92 buckled and kinked.The physician decided to aspirate on the cereglide 92 (cg), and 10cm worth of clot was suctioned out through the cg92 in one pass.Tici 3 was achieved.The physician did have difficulty in removing the cg92 since it had folded at the kink location, but was finally able to use the 8fr cook shuttle to advance over the kinked portion of the cg92 and removed both.Additional event information received on 28-aug-2025 indicated that the lot number is not available.There was no excessive force used with the device.The vessel was not tortuous, normal type 1 arch.There was no allegation of patient injury due to an alleged product issue.
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 a during a mechanical thrombectomy, a cereglide 92 catheter (sbc92122ug, lot unknown) was being advanced to the middle cerebral artery (mca) during an ischemic stroke, the middle portion of the cereglide 92 buckled and kinked.The physician decided to aspirate on the cereglide 92 (cg), and 10cm worth of clot was suctioned out through the cg92 in one pass.Tici 3 was achieved.The physician did have difficulty in removing the cg92 since it had folded at the kink location but was finally able to use the 8fr cook shuttle to advance over the kinked portion of the cg92 and removed both.Additional event information received on 28-aug-2025 indicated that the lot number is not available.There was no excessive force used with the device.The vessel was not tortuous, normal type 1 arch.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.The lot number is not known; therefore, a device history record review cannot be completed.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Catheter kinking during clinical use is a known and common occurrence and is typically related to anatomy, technique, physician skill, and vessel tortuousity.If the operator encounters kinking or damage during clinical use, they are clinically trained to immediately discontinue manipulations and remove the product.This may require insertion of an additional device, which can cause intra-procedure prolongation.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, 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: 22952309
• Report Number: 3007628272-2025-00045
• Device Sequence Number: 18608735
• Product Code: QJP
• UDI-Device Identifier: 10886704086048
• UDI-Public: (01)10886704086048
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K230726
• 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): 09/17/2025

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: SBC92122UG
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: SHUTTLE® GUIDING SHEATH (COOK MEDICAL).
• Patient Sex: Unknown