MAUDE Adverse Event Report: MICROVENTION INC. HYDROSOFT 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	7110-0258-3D-A2
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient came to operating room for endovascular procedure with stent.While deploying stent through deployment system, system partially fails and tip of deployment system becomes dislodged.Tip is retrieved from inside patient, no foreign body left in patient.Stent is an abbott supera peripheral stent system.

• Brand Name: HYDROSOFT 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 23802268
• Report Number: 23802268
• Device Sequence Number: 21172242
• Product Code: KRD
• UDI-Device Identifier: 00816777025449
• UDI-Public: (01)00816777025449
• 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): 12/03/2025
• Report Date (Section F): 12/03/2025

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: 7110-0258-3D-A2
• Device Catalogue Number: 7110-0258
• Device Lot Number: 0001214121
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2025
• 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 Age: 78 YR
• Patient Sex: Male
• Date Report Sent to FDA: 12/03/2025