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

Model Number	100304H2HS-V
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
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 evaluation but has not yet been returned despite a device return attempt.Ongoing attempts will be made for the device return.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Event or Problem Description
As reported: dr.Was treating a ruptured pica aneurysm on the right.A coil embolization was planned as the treatment.After placing several mv coils, a hydrosoft 3-4 was chosen.The coil had to be repositioned in the aneurysm.When dr.Tried to remove the coil from the aneurysm, it prematurely detached.There was only one loop remaining in the aneurysm.Dr.Was able to remove the coil from the aneurysm and patient body by pulling back the microcatheter.Coil and microcatheter were removed from the patient body completely.The coil was exchanged to a hydrosoft of same size and the examination completed.The patient is doing well.No injury caused by this issue.
Additional Manufacturer Narrative
The investigation of the returned coil system found the pusher bodycoil slightly stretched with waviness at the transition area, and the implant slightly stretched, separated from the pusher and stuck within the microcatheter, which is consistent with the alleged product issue.However, no indications of activation using a detachment controller was found on the pusher heater coil.The investigation found the pusher's monofilament with a tensile break shape at the tip, which is consistent with the device experiencing force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the stretched pusher and implant, but the damage is consistent with the device experiencing forces exceeding the pusher and implant's yield strength.The returned microcatheter was not found to be kinked or damaged and would not have caused or contributed to the reported complaint.
Event or Problem Description
No additional information received regarding the event.

• 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: 24283737
• Report Number: 2032493-2026-00066
• Device Sequence Number: 15545017
• Product Code: KRD
• UDI-Device Identifier: 00816777021403
• UDI-Public: (01)00816777021403(11)240702(17)290630(10)0000643854
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: 100304H2HS-V
• Device Lot Number: 0000643854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• 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: ECHELON 10 MICROCATHETER.
• Patient Age: 43 YR
• Patient Sex: Female