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

Catalog Number	NIC71125C
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b )(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section d2b: procode is nry/qjp section e1.Initial reporter phone: (b)(6).The complaint was submitted with a photograph of the device, which is pending further analysis.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 31395151 number, and no non-conformances related to the malfunction were identified.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 company is seeking this information through the event investigation.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, a 125cm cereglide 71 catheter (nic71125c, 31395151) was pushed at the access, till the very end touching the y adaptor.Probably due to the manipulation and contact to the access system the proximal ¿neck¿ of the cereglide shaft was broken and air was (would) enter the system while aspiration through a whole.They did not continue and changed the catheter to another competitive brand and continued successfully with the procedure, no significant delay, no additional risk, no harm happened to the patient.The physician admitted that he might should have used a longer cereglide to avoid irritation at the proximal neck, but he stated that this is unexpected that this would cause damage, since other aspiration catheters withstand this type of manipulation.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this med watch report: b4, g6, h2, h3, h6 and h11.Complaint conclusion: as reported by the field, a 125cm cereglide 71 catheter (nic71125c, 31395151) was pushed at the access, till the very end touching the y adaptor.Probably due to the manipulation and contact to the access system the proximal ¿neck¿ of the cereglide shaft was broken and air was (would) entering the system while aspiration through a hole.They did not continue and changed the catheter to another competitive brand and continued successfully with the procedure, no significant delay, no additional risk, no harm happened to the patient.The physician admitted that he might should have used a longer cereglide to avoid irritation at the proximal neck, but he stated that this is unexpected that this would cause damage, since other aspiration catheters withstand this type of manipulation.No additional information is available.One photo accompanied the complaint file.In the photo, the shaft of the cereglide catheter can be seen kinked next to the strain relief of the id band at the luer hub.No other damages are observed.A manufacturing record evaluation was performed for the finished device 31395151 number, and no non-conformances related to the malfunction were identified.The issue reported regarding the air leakage cannot be evaluated through a photo since a functional analysis is needed; however, the issue regarding the cracked condition on the catheter is confirmed based on the kinked condition observed on the photo.This investigation was performed based only on the photo provided.According to the information received the device was discarded and is not available for evaluation.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.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Updated sections on this med watch: b4, b5, g3, g6, h2, and h11.Section b5:.Additional event information received on 21-jan-2025 indicated that there was no possibility of air being injected into the patient.The device had not been re-shaped after removal from packaging.There was no difficulty attaching another device to the complaint device.The device was not advanced or withdrawn against resistance.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: 21055922
• Report Number: 3007628272-2025-00001
• Device Sequence Number: 15642925
• Product Code: NRY
• UDI-Device Identifier: 10886704085423
• UDI-Public: (01)10886704085423(17)270630(10)31395151
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2025

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: NIC71125C
• Device Lot Number: 31395151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2024
• Supplement Date Received by Manufacturer: 01/14/2025; 01/21/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 01/15/2025; 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2024
• 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