MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENVOY; PERCUTANEOUS CATHETER

Catalog Number	67125805D
Medical Device Problem Codes	Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
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 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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 an endovascular embolization, an envoy da, 6f, 105cm, mpd guide catheter (67125805d, 31282758) was impeded in c1 segment of carotid artery and could not deliver to the target site.Doctor removed the guide catheter from patient and found that the distal end of the guide catheter was kinked/bent.The doctor switched to a new guide catheter and delivered it in place.Then a prowler select plus 150/5cm microcatheter (606s255x, 31537084) was delivered and placed and then an unspecified stent was delivered in the microcatheter (mc).The stent was impeded in distal end of microcatheter and could not pass through the microcatheter.The doctor removed the stent and microcatheter from the patient and switched to a new microcatheter to deliver the original stent and completed the procedure.The surgery was prolonged about 10 minutes.There was no patient injury reported.Additional event information received on 04-jul-2025 indicated that the stent was an enterprise2 4mmx23mm (encr402312, lot unknown).There was no torque device used.There was no evidence of physical material within the devices.The microcatheter was not kink/bent.There was no excessive force used with the devices.There were no vessel or aneurysm factors that may have contributed to the events.The 10 minutes procedure prolongation did not result in a patient adverse consequence.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3, and h11.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, and h11.On 18-aug-2025, it was discovered this event no longer meets us fda reporting guidelines.Therefore, we are un-reporting the event.

• Brand Name: ENVOY
• Common Device Name: PERCUTANEOUS CATHETER
• 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: 22468858
• Report Number: 3008114965-2025-00711
• Device Sequence Number: 4272783
• Product Code: DQY
• UDI-Device Identifier: 10878528000676
• UDI-Public: (01)10878528000676(17)270228(10)31282758
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K000715
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2025

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: 67125805D
• Device Lot Number: 31282758
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 07/29/2025; 08/18/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/13/2025; 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2024
• 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