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

Catalog Number	67125605DB
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
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.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 (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 xb, 6f, 105cm, mpc guide catheter (67125605db, 31242284) was delivered to the patient.The proximal end of this guide catheter was observed to be kinked/bent.The doctor removed the guide catheter from the patient and switched to another guide catheter with the same unspecified microcatheter.Additional event information received on 04-jul-2025 indicated that the microcatheter used was a prowler select plus 150/5cm (606s255x, lot unknown).The device deficiency did not result in patient harm.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4) updated sections on this medwatch: b4, g3, g6, h2, and h11.On (b)(6) 2025 it was discovered this event no longer meets us fda reporting guidelines.

• 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 ; MX
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22494094
• Report Number: 3008114965-2025-00725
• Device Sequence Number: 18127736
• Product Code: DQY
• UDI-Device Identifier: 10886704075080
• UDI-Public: (01)10886704075080(17)261231(10)31242284
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 67125605DB
• Device Lot Number: 31242284
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PROWLER SELECT PLUS 150/5CM.
• Patient Sex: Unknown