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

Catalog Number	GS9090SD
Medical Device Problem Codes	Crack (1135); Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Prior to the start of an endovascular embolization procedure, it was reported that the physician opened the device packaging for a 90 cm cerebase straight distal access (da) guide sheath (gs9090sd / 31749653) for inspection.The proximal end of the cerebase catheter was found cracked.The device was not used for the procedure in the patient.A new device was used to complete the procedure.There was no negative impact on the patient.On 13-may-2026, additional information was received.The information indicated that the device packaging is available for return.The sterility seal was compromised.The replacement device was another 90 cm cerebase straight distal access (da) guide sheath (gs9090sd).
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 e.1: initial reporter facility name: per new requirement from (b)(6), in case complaint reporter¿s hospital is related to (b)(6) the name of such employer should be desensitized and redacted prior to be transferred abroad.The account name and facility name were not allowed to be displayed in the relevant area.Section e.1: the initial reporter phone: (b)(6) section h.3: 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.A review of manufacturing documentation associated with this lot (31749653) 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.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.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: 25222550
• Report Number: 3008114965-2026-00679
• Device Sequence Number: 15905197
• Product Code: QJP
• UDI-Device Identifier: 10886704082293
• UDI-Public: (01)10886704082293(17)271031(10)31749653
• 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): 06/17/2026

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: 31749653
• 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: 05/09/2026
• Supplement Date Received by Manufacturer: 05/22/2026; 06/12/2026; 06/17/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 05/22/2026; 06/12/2026; 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2025
• 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