MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT-10-AV; DEVICE NEUROVASCULAR EMBOLIZATION

Model Number	100520H2HS-V-A2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was stated to be available for return to the manufacturer for analysis.However, it has not yet been returned.The alleged product issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental report will be submitted.
Event or Problem Description
It was reported that after the embolization coil implant was introduced into the microcatheter and positioned within the aneurysm, the physician attempted to detach the coil using the detachment device.At that point, it became apparent that the proximal end of the delivery pusher designed to be inserted into the detachment device was missing.As a result, the coil had to be withdrawn from the aneurysm back into the microcatheter and subsequently removed completely from the body.The procedure was completed with the new coil.The broken or missing part of the pusher was outside of the patient's body.The was no patient injury and their condition was reported as stable.

• Brand Name: HYDROSOFT-10-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 ; 7142478000
• MDR Report Key: 25323333
• Report Number: 2032493-2026-00340
• Device Sequence Number: 5291575
• Product Code: HCG
• UDI-Device Identifier: 00816777023018
• UDI-Public: 00816777023018
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K091641
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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: 100520H2HS-V-A2
• Device Lot Number: 0001471054
• 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: 05/05/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2025
• 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