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

Catalog Number	GS9090SD
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).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.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.
Event or Problem Description
The healthcare professional reported that prior to the procedure, the outer packaging and the cerebase 90, 90 cm, straight, distal (gs9090sd/31450746) were inspected and found in good condition.When the luer hub of the cerebase catheter was connected to the y-connector, it was observed that the luer hub of the cerebase was broken.The catheter was not used in the patient.A new catheter was switched to complete the procedure.No patient injuries nor consequences were reported.
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4) updated sections on this medwatch: b4, g3, g6, h2, and h11.Kindly be informed that the summary of the photos visual analysis was inadvertently omitted from the initial medwatch report.The corresponding codes for section h6 (component code, type of investigation, investigation findings, and investigation conclusion) were included in the initial medwatch report.Photo analysis summary: two photos accompanied the complaint file.The first photo shows a y-connector, and no damages can be seen.The second photo shows the luer hub of a cerebase, and the rim can be seen broken with missing pieces.No other damages can be seen.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The customer complaint was confirmed.This investigation was performed based only on the photo provided.An assessment will be performed as per the conditions of the device returned.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 capa activity is required.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.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, d9, g3, g6, h2, h3 and h11.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Complaint conclusion: the healthcare professional reported that prior to the procedure, the outer packaging and the cerebase 90, 90 cm, straight, distal (gs9090sd/31450746) were inspected and found in good condition.When the luer hub of the cerebase catheter was connected to the y-connector, it was observed that the luer hub of the cerebase was broken.The catheter was not used in the patient.A new catheter was switched to complete the procedure.No patient injuries nor consequences were reported.No additional information was provided.Two photos accompanied the complaint file.The first photo shows a y-connector, and no damage can be seen.The second photo shows the luer hub of a cerebase, and the rim can be seen broken with missing pieces.No other damage can be seen.The device was returned to j&j medtech for further evaluation.A non-sterile gs 90, 90 cm, straight, distal was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and as seen in the provided picture the luer hub was found broken at the thread area with some missing parts.The issue reported that the hub of the catheter was broken was confirmed during the device inspection.Hub damage during attachment/removal of hemostasis valve is a potential failure mode that can result from the handling of hemostasis valve and hub where excessive force may have been applied, causing device damage.Devices undergo 100% inspection for hub damage during hub injection molding process.Thus, it is not likely that the device left the facility in a damaged condition; intra-operative factors may have contributed to the issue reported, however, with the amount of information available, a root cause cannot be established.A manufacturing record evaluation was performed for the finished device 31450746 number, and no non-conformance's related to the malfunction were identified.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 32574 ; MX 32574
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22282881
• Report Number: 3008114965-2025-00597
• Device Sequence Number: 8893271
• Product Code: QJP
• UDI-Device Identifier: 10886704082293
• UDI-Public: (01)10886704082293(17)261130(10)31450746
• 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,Followup
• Report Date (Section B): 08/27/2025

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: GS9090SD
• Device Lot Number: 31450746
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 06/03/2025; 06/25/2025; 08/26/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 06/20/2025; 06/26/2025; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown