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

Catalog Number	GS9080SD
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an endovascular embolization, after a cerebase 90, 80 cm, straight, distal catheter (product code: gs9080sd, lot number: 31194710) was advanced to the target site, the doctor delivered an intermediate catheter (other brand) in cerebase.The intermediate catheter was impeded in the hub of cerebase and could not advance any more.The doctor found that the section near cerebase hub was kinked/bent.The doctor removed the cerebase and the intermediate catheter from the patient and switched a new cerebase to complete the procedure with the same intermediate catheter.The outer packaging and device were inspected and found in good condition prior to the surgery.Additional event information indicated that there was no undue procedural delay associated with the event that could be considered clinically significant.The intermediate catheter used was unobtainable.The device did not appear physically damaged at any time.Continuous flush was maintained throughout.There was no break in material integrity at the site of the defect; no cracking or fracture was observed.Based on the product analysis of the device received, the body/shaft is fractured.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The device's body/shaft is fractured, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The device was returned to j&j medtech for further evaluation.A non-sterile gs 90, 80 cm, straight, distal was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and the device was found to be fractured just next to the id band.The fracture was inspected under a microscope and it was observed that the internal braid wire was exposed.Elongation marks were noted on both edges.The other joints in the distal region of the catheter were intact, without obvious separations.The fracture surfaces of the vestamid shaft show stretching and tearing of the shaft material at the edges of the fracture, indicating material elongation and tearing.The catheter was confirmed to be within specifications for the inner diameter (id) and outer diameter (od).Although the obstructed condition reported could not be evaluated due to the fractured condition found; it is suggested that this condition may have contributed to the issue experienced during the procedure; based on this, the customer complaint is confirmed.The catheter was received with a fracture of the vestamid shaft.This is a known failure mode of the catheter and can occur on a properly fused catheter.The observed condition could be the result of several factors, including but not limited to procedural factors present in the operating room such as operator¿s technique.A manufacturing record evaluation was performed, and internal actions related to the reported complaint condition were identified.As part of the j&j medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest that the failure reported is related to manufacture or design, no internal action is required.The instructions for use (ifu) contain the following precautions: 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.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: CEREBASE
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 24134468
• Report Number: 3008114965-2026-00180
• Device Sequence Number: 14810029
• Product Code: QJP
• UDI-Device Identifier: 10886704082316
• UDI-Public: (01)10886704082316(17)251231(10)31194710
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K192806
• 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
• Report Date (Section B): 01/21/2026

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 Expiration Date: 12/31/2025
• Device Catalogue Number: GS9080SD
• Device Lot Number: 31194710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3007628272-02/02/2024-00
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTERMEDIATE CATHETER (UNSPECIFIED BRAND)
• Patient Sex: Unknown