MAUDE Adverse Event Report: CERENOVUS, INC. CEREGLIDE; CATHETER, THROMBUS RETRIEVER

Catalog Number	NIC71132U
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	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 d.2b: procode is nry/qjp.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 (31303031) 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.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 a procedure, ¿we had two cereglide catheters where the hubs were cracked ¿ drawing air.¿ the two 132cm cereglide 71 intermediate catheter (nic71132u) were from two different lots: the first cereglide is from lot 31303031 and the second cereglide is from lot 31411523.There was no report of any patient impact.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 14-jan-2025.[additional information]: on 14-jan-2025, additional information was received.The information indicated that the patient is a 68-year-old female.The procedure was a thrombectomy targeting the middle cerebral artery (mca).The two cereglide catheters were used during the same procedure.The replacement was another cereglide catheter.The information confirmed the procedure was successfully completed with the new replacement cereglide.There was no negative patient impact and no delay in the procedure from the reported issue.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 28-jan-2025.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: (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 132cm cereglide 71 intermediate catheter was received contained in the decontamination pouch.Visual inspection was performed.No appearance of damages was observed.The returned cereglide intermediate catheter was flushed using a lab sample syringe with water.Water leak was observed at the hub section.Microscopic inspection was performed.Under magnification, it was noted that the hub appeared to have been subjected to force, which caused the outer plastic layer to fracture, slightly exposing the internal wires.However, the device remained in one piece connected by the internal braided wires.The issue reported that the device was cracked and drawing air were confirmed during the inspection.According to risk documentation hub damage during attachment of hemostasis valve is a potential failure mode that can result from the handling of hemostasis valve and hub, where excessive force could have been applied, leading to damage to the device.Devices undergo 100% inspection for exposed wire inside the hub during hub injection molding process, and 100% inspection for catheter kinks or damages during catheter loading into hoop.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 review of manufacturing documentation associated with this lot (31303031) 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.Although no conclusion could be reached as to the cause of the event reported, the instructions for use (ifu) contains the following precautions: before removing the intermediate catheter from the packaging hoop dispenser, rotate the luer on the packaging hoop 90 degrees.Gently remove the catheter and accessories from the hoop and inspect prior to use to verify that they are undamaged.Caution: do not use a catheter that has been damaged in any way.If damage is detected, replace with another catheter that is not damaged.Do not advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the device against resistance could damage the device or cause patient injury.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.Updated sections: b.4, 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.

• Brand Name: CEREGLIDE
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• 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: 21020001
• Report Number: 3007628272-2024-00071
• Device Sequence Number: 11792352
• Product Code: NRY
• UDI-Device Identifier: 10886704085409
• UDI-Public: (01)10886704085409(11)240405(17)270331(10)31303031
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/07/2025

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: NIC71132U
• Device Lot Number: 31303031
• 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: 12/11/2024
• Supplement Date Received by Manufacturer: 01/14/2025; 01/28/2025; 02/07/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 01/14/2025; 01/28/2025; 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2024
• 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 Age: 68 YR
• Patient Sex: Female