MAUDE Adverse Event Report: Medos International SARL ENVOY; Percutaneous Catheter

Catalog Number	67125805D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during the procedure, an envoy da, 6f, 105cm, mpd guide catheter (product code: 67125805d, lot number: 31858974) was in place.A micro-guidewire and microcatheter (both were other brands) were impeded in the middle section of the guide catheter and could not advance any more.The doctor removed the guide catheter, micro-guidewire and microcatheter from the patient together, then switched to a new guide catheter to complete surgery with the original micro-guidewire and microcatheter.There was no patient injury reported.Additional event information received on 31-jul-2026 indicated that they were able to move the device.They were not able to torque the device.There was no evidence of physical material within the device.There was no difficulty removing the device from the patient.There was no procedure delayed/prolonged due to the event.
Additional Manufacturer Narrative
Manufacturer ref# pc-002222933 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 31858974 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.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 internal 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): 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: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50209540
• Report Number: 3008114965-2026-01084
• Device Sequence Number: 12289794
• Product Code: DQY
• UDI-Device Identifier: 10878528000676
• UDI-Public: (01)10878528000676(17)290131(10)31858974
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/11/2026

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: 67125805D
• Device Lot Number: 31858974
• 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: 07/27/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2026
• 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