MAUDE Adverse Event Report: MicroVention, Inc. HydroSoft-3D-AV; Device, Neurovascular Embolization

Model Number	100152HFRM-V-3D-A2
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction

• Brand Name: HydroSoft-3D-AV
• Common Device Name: Device, Neurovascular Embolization
• Manufacturer (Section D): MicroVention, Inc.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; +1(714)247-8000
• MDR Report Key: 50953606
• Report Number: 2032493-2026-08273
• Device Sequence Number: 13369252
• Product Code: HCG
• UDI-Device Identifier: 00816777026453
• UDI-Public: (01)00816777026453(11)260311(17)310228(10)0001606580
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 100152HFRM-V-3D-A2
• Device Lot Number: 0001606580
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown