MAUDE Adverse Event Report: CERENOVUS, INC. ENVOY; PERCUTANEOUS CATHETER

Catalog Number	67026090
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.(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 is not available / reported.A review of manufacturing documentation associated with this lot (31040775) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances 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.
Event or Problem Description
The healthcare professional reported that during an interventional endovascular procedure targeting an arteriovenous malformation (avm), the physician was gaining access to the artery while advancing a 6f 90 cm, straight envoy® guiding catheter (67026090 / 31040775) when it was noticed that blood was leaking around the hub of the catheter where the yellow hub meets the white id band.The envoy was removed and replaced with a new one and the procedure went forward successfully.There was no negative impact to the patient.On 04-nov-2024, additional information was received.Per the information, the location of the avm and vessel characteristics (vessel tortuosity or acute bends) are not known.The replacement device was another envoy (67026090).
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 26-nov-2024.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, g.3, g.6.H.2, h.3, h.6, and h.11.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: pc-(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 6f 90 cm, straight envoy® guiding catheter was received contained in the decontamination pouch.Visual inspection was performed.The hub was noted to be cracked.A manufacturing investigation was performed.Manufacturing investigation: the process was analyzed by the manufacturing, quality, and engineering team to determine the possible cause of the hub damage and whether it is related to the envoy gc process.An analysis with regular production parts were performed in the production area with the normal process to mold the hub, the resin was dried as required per a minimum of 4 hours, however, it was not able to reproduce the defect with standard production parts following the required procedures.Currently the manufacturing line has controls to detect these defects through 100% visual inspections.Additionally, to these inspections: visual, torque, transversal, and hydrostatic.Which are critical to ensuring the product's integrity before it moves forward in the process.Fourier transform infrared spectroscopy (ftir): results demonstrate that the polycarbonate material from the control sample and the suspect hub present the same chemical behavior with no prominent differences.Material degradation or chemical modification is ruled out as main cause of fracture.Conclusion: the manufacturing process has been ruled out as the root cause of the defect, specifically with no evidence pointing to the hub being broken during production.Additionally, the ftir results did not show any discrepancies or unexpected peaks, it could indicate that the resin has been affected by something during the manufacturing or storage process such as exposure to moisture, contaminants, or other chemicals that could lead to the observed defect.Manufacturing process is excluded as a root cause for the issue.A review of manufacturing documentation associated with this lot (31040775) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.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): CERENOVUS, INC.; 6303 waterford district drive; suites 215 & 315; miami FL 33126
• 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: 20613941
• Report Number: 3007628272-2024-00055
• Device Sequence Number: 8906048
• Product Code: DQY
• UDI-Device Identifier: 10886704031796
• UDI-Public: (01)10886704031796(11)230324(17)260228(10)31040775
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2025

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 67026090
• Device Lot Number: 31040775
• 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: 10/29/2024
• Supplement Date Received by Manufacturer: 11/26/2024; 03/03/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 11/27/2024; 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• 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