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

Catalog Number	GS9095SD
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that a cerebase gs 90, 95 cm, straight distal catheter (product code: gs9095sd, lot number: 31756112) was being given contrast, however, it didn't reach the distal end of the cerebase.On imaging, the user realized that it was coming out of the proximal end (as well as blood) slightly above the hub.There was a kink.No patient injury was reported.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4) information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section b3 ¿ date of event: the date of the event was not reported.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.The company is seeking this information through the event investigation.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.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3, h6 and h11.Correction to section d9: updated it to: the fields ¿device available for evaluation,¿ ¿date device was returned to manufacturer,¿ and ¿is device returned to manufacturer¿ were inadvertently not completed on the initial medwatch report (b)(4).The device was returned to j&j medtech for further evaluation.A non-sterile cerebase gs 90, 95 cm, straight distal catheter was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the shaft was fractured next to the id band.One bent was found at 73 cm from the proximal end of the catheter.No other damage was found.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.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.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.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: ¿ exercise care in handling the cerebase da guide sheath 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
• 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: 24726821
• Report Number: 3008114965-2026-00473
• Device Sequence Number: 13065117
• Product Code: QJP
• UDI-Device Identifier: 10886704082323
• UDI-Public: (01)10886704082323(17)261031(10)31756112
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/10/2026

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: GS9095SD
• Device Lot Number: 31756112
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• 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