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

Model Number	100310H2HS-V
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
As reported: m2 bifurcation aneurysm with stent and coil implantation.The objective of the procedure was to recross the stent and implant more coils.Dr.Successfully recrossed the stent with a straight microcatheter.He then ordered the coil.The coil package was opened and its contents placed on the table.The dispenser cap was removed and the coil was removed.Its distal end was handed to the doctor, and the specialist held the proximal end.The doctor opened the hemostatic valve, inserted the distal end of the sheath, and closed the valve again.Saline return through the sheath was confirmed, and the coil was advanced until the proximal end was approximately one inch outside the sheath.The sheath was withdrawn, and the doctor continued advancing the device to the fluorosafe markers.Once under fluoroscopy, the doctor advanced the device and observed that the distal end of the coil was exiting the microcatheter.However, when he attempted to retrieve the device for better positioning, he noticed resistance.He attempted to advance and retrieve it again without success.At that point, the doctor noticed that the stretch-resistant element of the device had broken, so he decided to remove the microcatheter completely from the patient.The specialist confirmed the 'stuck' condition of the portion of the device that remained outside the microcatheter, as its proximal and other end were pulled.Due to this incident, the coil was replaced with another coil and the procedure was completed successfully.The patient is in good condition.

• 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: 21932424
• Report Number: 2032493-2025-90119
• Device Sequence Number: 18369522
• Product Code: HCG
• UDI-Device Identifier: 00816777022943
• UDI-Public: (01)00816777022943(11)241213(17)291130(10)0000823236
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

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: 100310H2HS-V
• Device Lot Number: 0000823236
• 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: 04/25/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2024
• 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: HEADWAY DUO (167 CM).
• Patient Age: 74 YR
• Patient Sex: Female