MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL N/A; CATHETER, PERCUTANEOUS

Catalog Number	IC71125UG
Medical Device Problem Codes	Failure to Advance (2524); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1.Initial reporter phone: (b)(6).Since no device has been received for analysis, no product investigation can be performed and the reported failure could not be evaluated.A manufacturing record evaluation was performed for the finished device 31512442 number, and no internal actions related to the malfunction were identified.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.The instructions for use (ifu) contain the following caution: ¿if strong resistance is met during manipulation, discontinue the procedure and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the catheter and guidewire as a system.Warning: never advance or withdraw an intraluminal device against resistance.Movement or force of catheter or guide wire against resistance could dislodge a clot, perforate a vessel wall, or severely damage the catheter and/or guide wire.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.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 during a stent-assisted coil embolization, a 125cm large bore 71 catheter (product code ic71125ug, lot number 31512442) and a prowler select plus 150/5cm microcatheter (product code 606s255x, lot number unknown) were delivered coaxially, with the microcatheter successfully passing through the end of the internal carotid artery.However, the large bore catheter was impeded at the end of the internal carotid artery and could not advance further.Upon removal, the shaft of the large bore catheter was observed to be kinked or bent.The physician switched to a new device to complete the surgery using the original microcatheter.There was no reported patient consequence or adverse impact, and no procedure prolongation or delay occurred due to the event.Additional event information received on 09-jan-2026 indicated that there was no evidence of physical material within the device.There was no excessive force used with the devices.There was no procedure prolongation/delay due to the event.Additional event information received on 12-jan-2026 indicated that it is unknown if the prowler select microcatheter was removed when the large bore catheter became impeded.

• Brand Name: N/A
• 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: 24116926
• Report Number: 3008114965-2026-00169
• Device Sequence Number: 5867098
• Product Code: DQY
• UDI-Device Identifier: 10886704082361
• UDI-Public: (01)10886704082361(17)260430(10)31512442
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K191237
• 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): 01/20/2026

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 Expiration Date: 04/30/2026
• Device Catalogue Number: IC71125UG
• Device Lot Number: 31512442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2024
• 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