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

Catalog Number	67125805D
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by a healthcare professional, prior to the procedure, the physician opened the packaging of an envoy da, 6f, 105cm, mpd catheter (67125805d, 31411030) for inspection.The proximal part of the guide catheter was found cracked.The device was not used in patient.A new device was switched to complete the surgery.Additional event information received on 16-may-2025 indicted that there was no other physical damage noted on the device.No excessive force was applied to the device at any point.There had not been any packaging issues.
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1.Initial reporter phone: (b)(6).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.
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).Complaint conclusion: as reported by a healthcare professional, prior to the procedure, the physician opened the packaging of an envoy da, 6f, 105cm, mpd catheter (67125805d, 31411030) for inspection.The proximal part of the guide catheter was found cracked.The device was not used in patient.A new device was switched to complete the surgery.Additional event information received on 16-may-2025 indicted that there was no other physical damage noted on the device.No excessive force was applied to the device at any point.There had not been any packaging issues.The device was returned to j&j medtech for further evaluation.A non-sterile envoy da, 6f, 105cm, mpd catheter was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, one kink and one compressed section was found on the shaft of the catheter.The kink condition was found at 30.0 cm, and the compressed condition was found at 99.5 cm.These measurements were taken from the proximal end of the catheter.The proximal end of the catheter was inspected under magnification and no cracks nor fractures were found neither on the luer hub nor the proximal end of the shaft.No exposed internal wires nor breaks in the device integrity were found.The catheter was flushed using a lab sample syringe, and no water leakage that could indicate of a crack was identified.A manufacturing record evaluation was performed for the finished device 31411030 number, and no non-conformances related to the malfunction were identified.Since no break in device integrity was found, the issue regarding a cracked condition on the proximal end of the catheter cannot be confirmed.There is no indication that the issue reported in the complaint is related to a manufacturing issue.The kink and compressed conditions were not originally reported, and the exact time of occurrence cannot be determined.It is suggested that these damages could be the result of the handling post-procedure of the device; therefore, these are not considered related to the issue reported.As part of the j&j medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required at this time.It should be noted that product failure is multifactorial.The instructions for use contain the following precaution: ¿ do not use a catheter that has been damaged in any way.If damage is detected, replace it 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.

• 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: 22043645
• Report Number: 3008114965-2025-00459
• Device Sequence Number: 21097631
• Product Code: DQY
• UDI-Device Identifier: 10878528000676
• UDI-Public: (01)10878528000676(17)270630(10)31411030
• 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,Followup
• Report Date (Section B): 06/17/2025

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: 31411030
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 06/09/2025; 06/16/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/10/2025; 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2024
• 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