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

Model Number	7210-0254
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: dr.Was performing a coiling of an mca bifurcation aneurysm.The 2.5/4cm hydrosoft was inserted but would not detach after placement.Dr.Tried to recapture the hydrosoft coil back into the microcatheter.During the attempted recapturing of the coil, it detached but left a portion of the proximal end of the coil in the parent vessel.Dr.Had to place a stent to secure the proximal end of the coil against the vessel wall.Case was completed with the aneurysm being coiled and a stent was placed to secure coil against vessel wall.Patient woke up neurologically intact and was fine post op 24 hours.
Additional Manufacturer Narrative
The physical device was not available for evaluation to investigate if a condition existed that would have contributed to the reported event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation further examine the cause of the reported event.This information may be updated if additional information is provided at a later date.

• Brand Name: HYDROSOFT-10-AV
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING 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: 22057476
• Report Number: 2032493-2025-90164
• Device Sequence Number: 12671166
• Product Code: KRD
• UDI-Device Identifier: 00816777023100
• UDI-Public: (01)00816777023100(11)231026(17)280930(10)0000451548
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K132952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7210-0254
• Device Lot Number: 0000451548
• Was Device Available for Evaluation?: No
• 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: 05/02/2025
• Initial Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEADWAY DUO 156.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown