MAUDE Adverse Event Report: MICROVENTION INC. COSMOS 18 ADVANCED; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number 8218-1139

Device Problems Entrapment of Device (1212); Fracture (1260); Stretched (1601)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/28/2023

Event Type  malfunction  

Event Description

Coil strand stretched and fractured and was retained in patient.

• Brand Name: COSMOS 18 ADVANCED
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise aliso; viejo CA 92656
• MDR Report Key: 16688885
• MDR Text Key: 312943230
• Report Number: 16688885
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00811425028773
• UDI-Public: (01)00811425028773
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8218-1139
• Device Catalogue Number: 8218-1139
• Device Lot Number: 0000245734
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29200 DA
• Patient Sex: Male
• Patient Weight: 55 KG