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

Catalog Number	67125805D
Medical Device Problem Codes	Crack (1135); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during an endovascular embolization procedure, the physician opened the device packaging for an envoy da guiding catheter 6f, 105cm, mpd (67125805d / 31289207) and the guide catheter was observed kinked / bent.The device was not used for the procedure in the patient.A new device was used to complete the procedure.There was no report of any negative patient impact.On 10-dec-2024, additional information was received.Per the information, there was no damage noted on the device packaging.There was no difficulty in removing the device from the packaging.There was cracking at the site of the defect.There was no delay in the procedure due to the reported issue.Based on the additional information received on 10-dec-2024, the event has been deemed usfda reportable under 21 cfr 803 with a classification of ¿malfunction.¿.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, sex, gender, weight, race, and ethnicity were not provided.Section e.1: the initial reporter phone: (b)(6).Section e.1: initial reporter facility name: (b)(6).Section h.3: 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.A review of manufacturing documentation associated with this lot (31289207) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no internal actions related to device manufacture or inspection.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 johnson & johnson medtech, or its employees that the report constitutes an admission that the product, johnson & johnson medtech, 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.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 manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 09-jan-2025.A supplemental 3500a report will be submitted once the product investigation has been completed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile envoy da guiding catheter 6f, 105cm, mpd was received contained in the decontamination pouch, folded inside the inner pouch.Visual inspection was performed.The device was observed still inside the protective tube.Two kinks were observed on the shaft of the catheter: the first kink is near the id band and the second kink is at 2cm from the proximal end.The outer packaging was not returned for evaluation.Microscopic inspection was performed at the site of the defect and no exposed internal wires nor breaks in the device integrity were found.The issue reported regarding the catheter being kinked was confirmed based on the damaged conditions found.The complaint documented that the device was already damaged when it was first opened; and this damage is suspected to be related to the manipulation exerted after unpacking the device.However, since no break in device integrity was found the issue regarding a catheter being cracked cannot be confirmed.There is no indication that the issue reported in the complaint is related to a manufacturing issue.A review of manufacturing documentation associated with this lot (31289207) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no internal actions related to device manufacture or inspection.As part of johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The instructions for use (ifu) contains 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.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 20926294
• Report Number: 3008114965-2024-01233
• Device Sequence Number: 5043211
• Product Code: DQY
• UDI-Device Identifier: 10878528000676
• UDI-Public: (01)10878528000676(11)240312(17)270228(10)31289207
• 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): 01/16/2025

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: 31289207
• 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: 12/10/2024
• Supplement Date Received by Manufacturer: 01/09/2025; 01/16/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/09/2025; 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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