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

Catalog Number	67125895D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.(b)(4).Section e.1: the initial reporter phone is not available / reported.The extra device received underwent evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile envoy da, 6f, 95cm, mpd from lot number 31253180 was received contained in the decontamination pouch.Visual inspection was performed.A crack was noted on the luer hub of the catheter.Microscopic inspection was performed, and a prominent line was noted at the fusion joint of the hub.The hub was connected to a lab-sample syringe, and when the connector exerted pressure upon the hub, the line opened exposing the cracked condition at the fusion joint.A review of manufacturing documentation associated with this lot (31253180) 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.Although there is no alleged quality issue against the catheter, as a result of the cracked conditions on hubs for this product family, corrective actions are being addressed through j&j medtech quality system.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.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.
Event or Problem Description
The healthcare professional reported that during the procedure, the hub of the envoy da, 6f, 95cm, mpd (67125895d / 31253180) was kinked and there was leakage of saline.The physician replaced the device with a ¿same like¿ product and the procedure was successfully completed.There was no report of any negative patient impact.On 23-jan-2025, the complaint product was received in the product analysis lab.There were two envoy da, 6f, 95cm, mpd (67125895d) from the same lot number (31253180).One of the devices belong to the complaint and was investigated.On 04-mar-2025, an email response was received from the south korea bq team related to the extra product: "i¿ve confirmed 1 complaint sample is right and the additional one is mistakenly shipped with a complaint sample after interviewing sale ref." based on the result of the product analysis completed on 12-mar-2025, the reported issue meets usfda reporting criteria under 21 cfr 803 as a "malfunction.".

• 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 ; 303552-6892
• MDR Report Key: 21586979
• Report Number: 3008114965-2025-00213
• Device Sequence Number: 8757811
• Product Code: DQY
• UDI-Device Identifier: 10878528000652
• UDI-Public: (01)10878528000652(11)240213(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
• Report Date (Section B): 03/12/2025

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
• Date Returned to Manufacturer: 01/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 03/12/2025
• 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