MAUDE Adverse Event Report: CERENOVUS, INC. ENVOY; PERCUTANEOUS CATHETER

Catalog Number	67025800
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during a coil embolization, an envoy 6f, mpd 100cm guide catheter (product code: 67025800, lot number: 31312323) was delivered in place and then an unspecified microcatheter (mc) was delivered in the guide catheter.The microcatheter was impeded in the distal end of the guide catheter and could not pass through the guide catheter.The doctor removed the guide catheter and microcatheter from the patient, the guide catheter tip was found kinked/bent.The doctor switched to a new guide catheter to complete surgery with the original microcatheter.The surgery was prolonged by about 10 minutes.Prior to the procedure, the device outer packaging and the device were inspected and found in good condition.Additional event information received on 08-jun-2026 indicated that there was flushing during the procedure.There was no evidence of physical material within the device.There was no excessive force used with the devices.There was procedure prolongation/delay due to the event, however, it did not result in a patient adverse consequence.
Additional Manufacturer Narrative
Manufacturer ref (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device 31312323 number, and no non-conformances 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.Catheter obstruction in patient with loss of cerebral target position is a known potential complication associated with this device.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.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.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.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.

• Brand Name: ENVOY
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): CERENOVUS, INC.; 6303 waterford district drive; suites 215 & 315; miami FL 33126
• 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: 25523430
• Report Number: 3007628272-2026-00051
• Device Sequence Number: 13418702
• Product Code: DQY
• UDI-Device Identifier: 10886704031734
• UDI-Public: (01)10886704031734(17)270331(10)31312323
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093184
• 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): 06/16/2026

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: 67025800
• Device Lot Number: 31312323
• 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: 06/03/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• 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