MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT 10; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	7110-0208-3D-A2
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a coil embolization of a middle cerebral artery (mca) aneurysm, a 2mm x 8mm hydrosoft coil by microvention was being used in the brain and as it was trying to be detached it was not working.Coil was then removed from the head.When the catheter the coil was inside was removed and the coil was taken out, it unraveled and still would not detach.

• Brand Name: HYDROSOFT 10
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 13938044
• Report Number: 13938044
• Device Sequence Number: 4476298
• Product Code: KRD
• UDI-Device Identifier: 00816777025401
• UDI-Public: (01)00816777025401(11)210727(17)260630(10)2107275P6
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2022
• Report Date (Section F): 03/15/2022

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: 7110-0208-3D-A2
• Device Catalogue Number: 7110-0208
• Device Lot Number: 2107275P6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2022
• 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: Female
• Date Report Sent to FDA: 03/15/2022