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

Catalog Number	NIC71132C
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Section d2b: procode is nry/qjp.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.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.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.
Event or Problem Description
As reported by the field, an132cm cereglide 71 catheter (nic71132c, 31364341) was broken at the hub after opening the box.There was no patient injury as the device was not clinically used.Additional event information received on 10-dec-2024 indicated that there were no packaging issues.No additional information is available.
Additional Manufacturer Narrative
Product complaint (b)(4).Updated sections on this med watch report: 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
Product complaint # (b)(4) updated sections on this medwatch.Complaint conclusion: as reported by the field, an132cm cereglide 71 catheter (nic71132c, 31364341) was broken at the hub after opening the box.There was no patient injury as the device was not clinically used.Additional event information received on 10-dec-2024 indicated that there were no packaging issues.No additional information is available.One non-sterile 132cm cereglide 71 catheter was returned in the decontamination pouch.Upon receipt of the device, visual inspection was performed, and the hub was noted to be loose.No other damages were found in the device.Microscopic examination was performed.Under magnification, it was noted that the hub had been subjected to force, which caused the outer plastic layer to fracture, exposing the internal wires.However, the device remained in one piece connected by the internal braided wires.The issue reported that the device was broken at the hub was 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 manufacturing record evaluation was performed for the finished device 31364341 number, and no non-conformances related to the malfunction were identified.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.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.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: CEREGLIDE
• Common Device Name: CATHETER, THROMBUS RETRIEVER CATHETER, PERCUTANEOUS, NEUROVASCULATURE
• 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 ; 3035526892
• MDR Report Key: 20916380
• Report Number: 3007628272-2024-00070
• Device Sequence Number: 7846080
• Product Code: NRY
• UDI-Device Identifier: 10886704085409
• UDI-Public: (01)10886704085409(17)270531(10)31364341
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: NIC71132C
• Device Lot Number: 31364341
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 01/09/2025; 02/07/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/09/2025; 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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