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

Catalog Number	GS9090SD
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during a procedure, the proximal body of the 90 cm cerebase straight distal access (da) guide sheath (gs9090sd / 31580143) was kinked when the device was locked with the y-connector.There was no report of any negative patient impact.On 02-may-2026, additional information was received.Per the information, the kink occurred in patient, prior to aspiration or delivery the stent retriever.The cerebase had to be removed and replaced to continue the procedure.There was no negative impact on the patient.There was no procedure delay due to the issue.The additional information did not include the event date.The complaint device was returned for evaluation and analysis.The product investigation completed on 12-jun-2026.Based on the completed product investigation, this event has been determined to be usfda reportable under 21 cfr 803 with a classification of ¿malfunction.¿.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, sex, gender, weight, race, and ethnicity were not provided.Section b.3: date of event: the date of the event was not reported / known.Section e.1: the initial reporter phone is not available / reported.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 90 cm cerebase straight distal access (da) guide sheath was received contained in the decontamination pouch.Visual inspection was performed.The shaft has a fracture next to the id band.Additionally, a compressed area was found at 0.7 cm from the distal end.Microscopic inspection was performed on the fracture site, and it was observed that the internal wire was exposed.The reported issue regarding the proximal body kink is confirmed based on the fractured condition found.The fracture 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.The compressed condition is suspected to have appeared during the post-processing handling of the device as it was not originally reported in the complaint; therefore, it is not considered related to the complaint.A review of manufacturing documentation associated with this lot (31580143) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no internal actions related to device manufacture or inspection.As part of johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.The instruction for use (ifu) contains the following caution: exercise care in handling the cerebase da guide sheath to reduce the chance of accidental damage.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• 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 ; 949788-2078
• MDR Report Key: 25492053
• Report Number: 3008114965-2026-00832
• Device Sequence Number: 21266048
• Product Code: QJP
• UDI-Device Identifier: 10886704082293
• UDI-Public: (01)10886704082293(17)270531(10)31580143
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 06/12/2026

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: 31580143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2025
• 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