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

Model Number	8218-1139
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Coil strand stretched and fractured and was retained in patient.

• Brand Name: COSMOS 18 ADVANCED
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise aliso; viejo CA 92656
• MDR Report Key: 16688885
• Report Number: 16688885
• Device Sequence Number: 17624886
• Product Code: KRD
• UDI-Device Identifier: 00811425028773
• UDI-Public: (01)00811425028773
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/15/2023
• Report Date (Section F): 03/15/2023

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 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
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 55 KG
• Date Report Sent to FDA: 03/15/2023