Ibraheem Alkhawaldeh, Ahmed Aljabali, Mostafa Hossam El Din Moawad, Mahmoud Abualhayjaa, Hamza K Alsalhi
{"title":"Cerenovus CEREGLIDE 71中间导管的不良事件和失败：FDA MAUDE数据库的分析回顾","authors":"Ibraheem Alkhawaldeh, Ahmed Aljabali, Mostafa Hossam El Din Moawad, Mahmoud Abualhayjaa, Hamza K Alsalhi","doi":"10.7461/jcen.2025.E2025.01.004","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":94072,"journal":{"name":"Journal of cerebrovascular and endovascular neurosurgery","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Adverse events and failures with Cerenovus CEREGLIDE 71 Intermediate Catheter: An analytic review of the FDA MAUDE database.\",\"authors\":\"Ibraheem Alkhawaldeh, Ahmed Aljabali, Mostafa Hossam El Din Moawad, Mahmoud Abualhayjaa, Hamza K Alsalhi\",\"doi\":\"10.7461/jcen.2025.E2025.01.004\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":94072,\"journal\":{\"name\":\"Journal of cerebrovascular and endovascular neurosurgery\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-09-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of cerebrovascular and endovascular neurosurgery\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.7461/jcen.2025.E2025.01.004\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of cerebrovascular and endovascular neurosurgery","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.7461/jcen.2025.E2025.01.004","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Adverse events and failures with Cerenovus CEREGLIDE 71 Intermediate Catheter: An analytic review of the FDA MAUDE database.
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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