J Cerebrovasc Endovasc Neurosurg.
2025 Dec;27(4):338-345. 10.7461/jcen.2025.E2025.01.004.
Adverse events and failures with Cerenovus CEREGLIDE 71 Intermediate Catheter: An analytic review of the FDA MAUDE database
- Affiliations
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- 1Faculty of Medicine, Mutah University, Al-Karak, Jordan
- 2Jordan University of Science and Technology, Irbid, Jordan
- 3Alexanderia Main University Hospital, Alexanderia, Egypt
- 4Faculty of Medicine, The Hashemite University, Zarqa, Jordan
- KMID: 2575038
- DOI: http://doi.org/10.7461/jcen.2025.E2025.01.004
Abstract
Objective
To assess the safety and performance of the Cereglide 71 aspiration catheter, launched in February 2024, by analyzing adverse events from the Manufacturer and User Facility Device Experience (MAUDE) database.
Methods
Reports from the MAUDE database (February 2024 onward) were analyzed using Microsoft Excel and Jamovi, with 36 reports reviewed—27 device-related and 14 patient-related.
Results
The most common device-related issues were cracks (8 occurrences), material bending (6), and deformation/stretching (5). Adverse events included thromboembolism (4 cases), intracranial hemorrhage (2), carotid-cavernous fistula (2), and cerebral vasospasm (2). The most common indication was middle cerebral artery stroke (9 cases).
Conclusions
This study highlights the importance of post-market surveillance to improve patient outcomes, identifying key complications that require careful consideration in clinical practice. This is the first report on complications related to the Cereglide 71 aspiration catheter from the FDA MAUDE database.
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