MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÀRL CEREPAK FREEFORM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	MCR092040
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Thirteen devices that the coil would not deploy on two different patients.Lot numbers: 101456956, 31146338, 31077168, 31140719, 31077168, 31112710, 31098100, 31136064, 31162597, 31162597, 31146338, 31162598, 31107820.

• Brand Name: CEREPAK FREEFORM
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÀRL; 4600 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 18776969
• Report Number: 18776969
• Device Sequence Number: 8383557
• Product Code: KRD
• UDI-Device Identifier: 10886704083009
• UDI-Public: (01)10886704083009
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/09/2024
• Report Date (Section F): 02/09/2024

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
• Device Model Number: MCR092040
• Device Catalogue Number: MCR092040
• Device Lot Number: 101456956, 31146338, 31077168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/09/2024