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

Catalog Number	67125895D
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).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.The company is seeking this information through the event investigation.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
As reported by a healthcare professional, ¿part next to hub cracked¿ of an envoy da, 6f, 95cm, mpd guide catheter (67125895d, 31253180).No patient injury was reported.
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h3 and h11.Complaint conclusion: as reported by a healthcare professional, ¿part next to hub cracked¿ of an envoy da, 6f, 95cm, mpd guide catheter (67125895d, 31253180).No patient injury was reported.No additional information is available.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 31253180 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.The instructions for use (ifu) indicate to inspect the catheter upon removal from packaging to verify that it is undamaged.Warning: do not use a catheter that has been damaged in any way.If damage is detected, replace with another envoy guiding catheter that is not damaged.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.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 med watch: b4, d9, g3, g6, h2 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, h3, h6 and h11.The device was returned to j&j medtech for further evaluation.A non-sterile envoy da, 6f, 95cm, mpd was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and a black arrow was marked on the device hub indicating were the issue is located.Then, the hub was inspected under a microscope, and a cracked condition was found at the fusion area.The issue reported that the catheter hub was cracked was confirmed during the device inspection.Hub damage during attachment/removal of hemostasis valve is a potential failure mode that can result from the handling of hemostasis valve and hub where excessive force may have been applied, causing device damage.Devices undergo 100% inspection for hub damage during hub injection molding process.Thus, it is not likely that the device left the facility in a damaged condition; intra-operative factors may have contributed to the issue reported, however, with the amount of information available, a root cause cannot be established.A manufacturing record evaluation was performed for the finished device 31253180 number, and no non-conformances related to the malfunction were identified.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contain the following caution: do not use a catheter that has been dam aged in any way.If damage is detected, replace with another envoy guiding catheter that is not damaged.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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: 21910020
• Report Number: 3008114965-2025-00344
• Device Sequence Number: 14508571
• Product Code: DQY
• UDI-Device Identifier: 10878528000652
• UDI-Public: (01)10878528000652(17)270131(10)31253180
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup,Followup
• Report Date (Section B): 09/30/2025

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: 67125895D
• Device Lot Number: 31253180
• 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: 04/06/2025
• Supplement Date Received by Manufacturer: 07/01/2025; 07/30/2025; 09/29/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 07/01/2025; 08/19/2025; 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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