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	03/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).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.Two photos are attached to the complaint file.The first image captures a close up of the catheter shaft area with a crack in it, the second photo shows most of the catheter suspended and bent at the cracked site.No other damage was observed.A manufacturing record evaluation was performed for the finished device 31663274 number, and no internal actions related to the malfunction were identified.The issue regarding the shaft being cracked was confirmed based on the observed cracked condition.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 the j&j medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no internal action is required.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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 before the procedure, the physician opened the device packaging for inspection of a cerebase catheter.The shaft of the cerebase was found cracked.The device was not used in patient.A new cerebase was used to complete the surgery.There was no patient injury reported as the device was not clinically used.Additional event information received on 12-mar-2026 indicated that the device was stored and handled according to the instructions for use (ifu).There was no damage noted to the packaging.The integrity of the sterile pouch was not compromised.
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
Manufacturer ref# (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h3, h6 and h11.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 one (1) kinked condition was found on the shaft of the catheter at 35 cm from the proximal end of the catheter.No other damage was found.The kinked condition was inspected under magnification, and no breakage in the integrity of the shaft were noted.No internal components were exposed either.The catheter was flushed using a lab-sample syringe, and no water leakage from the kinked condition was identified.Although no break in device integrity was found during device inspection, the customer complaint can be confirmed based on the damaged condition found in the device, since this matches with the condition seen in the provided picture.With the information available, a conclusive cause cannot be determined; however, it is possible that clinical and procedural factors, including device manipulation and operator's technique, may have contributed to the reported failure.At this time, there is no evidence to support that the issue reported in the complaint is a result of a defect inherently related to the device.A manufacturing record evaluation was performed for the finished device (b)(6) number, and no internal actions related to the malfunction were identified.As part of j&j medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent damage from leaving the facility.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no internal action is required.It should be noted that product failure is multifactorial.The instructions for use (ifu) indicate the following precaution: to control the proper introduction, movement, positioning and removal of the guide sheath within the vascular system, users should employ standard clinical angiographic and fluoroscopic practices and techniques throughout the interventional procedure.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: 24625768
• Report Number: 3008114965-2026-00429
• Device Sequence Number: 21004839
• 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): 04/15/2026

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: 03/06/2026
• Supplement Date Received by Manufacturer: 04/09/2026; 04/14/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/10/2026; 04/15/2026
• 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