MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CEREBASE; CATHETER, PERCUTANEOUS, NEUROVASCULATURE

Catalog Number	GS9090SD
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
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 e1.Initial reporter phone: (b)(6).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.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 during a mechanical thrombectomy, after the cerebase guide sheath (product code: gs9090sd, lot number: 31711074) was positioned, the intermediate catheter (non j&j) became impeded at the distal end of the cerebase and was unable to advance through it.The physician removed both the cerebase and the intermediate catheter from the patient.A new cerebase was then introduced, and the procedure was successfully completed using the original intermediate catheter.No patient injury was reported.
Additional Manufacturer Narrative
Manufacturer ref#(b)(4).Updated sections on this medwatch: b4, d4, g3, g6, h2, h4 and h11.Additioanl event information received on 27-feb-2026 indicated that the correct product lot number for the device involved is 31663274.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, b5, d9, g3, g6, h2, h3, h6 and h11.Section b5: additional event information received on 24-mar-2026 indicated that there was no evidence of physical material within the device.The size and brand of the intermediate catheter is not available.The removal of the cerebase did not result in loss of cerebral target position.There was no excessive force used with the devices.There was no procedure prolongation/delay due to the event.Complaint conclusion: a healthcare professional reported that during a mechanical thrombectomy, after the cerebase guide sheath (product code: gs9090sd, lot number: 31663274) was positioned, the intermediate catheter (non j&j) became impeded at the distal end of the cerebase and was unable to advance through it.The physician removed both the cerebase and the intermediate catheter from the patient.A new cerebase was then introduced, and the procedure was successfully completed using the original intermediate catheter.No patient injury was reported.Additional event information received on 24-mar-2026 indicated that there was no evidence of physical material within the device.The size and brand of the intermediate catheter is not available.The removal of the cerebase did not result in loss of cerebral target position.There was no excessive force used with the devices.There was no procedure prolongation/delay due to the event.A non-sterile cerebase catheter was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the catheter was returned entangled with the dilator.Three kinks were found on the shaft jacket; the first at 3.5 cm, the second at 39.8 cm, and the third at 88 cm.These measurements were taken from the proximal end of the catheter.No additional damages on the shaft jacket were found under magnification.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint could not be evaluated due to the kinks found on the shaft jacket.These damages were not originally reported, and the exact time of occurrence cannot be determined; therefore, are not considered related to the failure reported.With the information available there is no indication that the issues reported in the complaint result from a defect inherently related to the device.As part of j&j medtech quality process all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no internal action activity is required.The instructions for use (ifu) contain the following caution: ¿if strong resistance is met during manipulation, discontinue the procedure and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the catheter and guidewire as a system.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: CEREBASE
• Common Device Name: CATHETER, PERCUTANEOUS, NEUROVASCULATURE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• 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: 24444154
• Report Number: 3008114965-2026-00331
• Device Sequence Number: 13355359
• Product Code: QJP
• UDI-Device Identifier: 10886704082293
• UDI-Public: (01)10886704082293(17)270731(10)31663274
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K192804
• 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): 03/26/2026

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: GS9090SD
• Device Lot Number: 31663274
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 02/28/2026; 03/17/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/11/2026; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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