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

Catalog Number	GS9090SD
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that prior to the procedure, the device package of a cerebase guide catheter (gs9090sd, 31395243) was inspected and in good condition.When connecting the cerebase to the y connector, it was observed that saline escaped from the connection of cerebase luer hub and the y connector.The doctor still used the cerebase to complete the surgery.There was no patient injury reported.Additional event information received on 08-jul-2025 indicated that the device did not appear kinked, compressed, cracked or damaged in any other way.There was no evidence of air being injected into the patient due to the leakage.The device deficiency did not result in patient harm.
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.One (1) picture was provided with the complaint report.The image shows the luer hub connected to an rhv.There appears to be fluid trickling through the connection of hub and rhv.No other relevant details or damage can be observed.A manufacturing record evaluation was performed for the finished device 31395243 number, and no non-conformances related to the malfunction were identified.The reported complaint regarding leakage at the hub was confirmed based on the conditions observed in the pictures.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.This investigation was performed based only on the photo provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.As part of johnson & johnson 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 capa activity is required.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.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.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3, h6 and h11.Complaint conclusion a healthcare professional reported that prior to the procedure, the device package of a cerebase guide catheter (gs9090sd, 31395243) was inspected and in good condition.When connecting the cerebase to the y connector, it was observed that saline escaped from the connection of cerebase luer hub and the y connector.The doctor still used the cerebase to complete the surgery.There was no patient injury reported.Additional event information received on 08-jul-2025 indicated that the device did not appear kinked, compressed, cracked or damaged in any other way.There was no evidence of air being injected into the patient due to the leakage.The device deficiency did not result in patient harm.One (1) picture was provided with the complaint report.The image shows the luer hub connected to an rhv.There appears to be fluid trickling through the connection of hub and rhv.No other relevant details or damage can be observed.The device was returned to j&j medtech for further evaluation.A non-sterile cerebase guide catheter was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and no appearance of damage was observed.The hub of the cerebase catheter was attached to a y-connector.The y-connector was attached to a lab sample syringe and absorbent paper towels were put down the hub and connector to identify liquid leakage.The catheter was flushed until liquid was noted to exit from the distal tip, and no leakage was noted from the hub nor the y-connector.The absorbent paper towels remained dried at the hub and y-connector area.A manufacturing record evaluation was performed for the finished device 31395243 number, and no non-conformances related to the malfunction were identified.The functional test was completed successfully, and no integrity issues were found with the device.As a result, the leakage condition could not be confirmed.However, it's possible that other factors or issues occurred during the device's use that could not be replicated during the analysis.As part of j&j medtech quality process all devices are manufactured, inspected, and released to approved specifications.Since no issues with the catheter were identified, no capa activity is required.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contain the following caution: exercise care in handling the intermediate catheter to reduce the chance of accidental damage.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 ; MX
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22441501
• Report Number: 3008114965-2025-00697
• Device Sequence Number: 18010816
• Product Code: QJP
• UDI-Device Identifier: 10886704082293
• UDI-Public: (01)10886704082293(17)260930(10)31395243
• 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
• Report Date (Section B): 08/12/2025

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 Expiration Date: 09/30/2026
• Device Catalogue Number: GS9090SD
• Device Lot Number: 31395243
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2024
• 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