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

Model Number	7110-0204
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product name, model, and lot were provided.As the lot number was not provided, a search for production-related non-conformance's could not be performed.The device was implanted and therefore not available for return and investigation by the manufacturer.The investigation is ongoing and upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
As reported: patient was admitted for evaluation of sudden onset of dizziness and nausea/vomiting.Per chart review, patient presented to the er for evaluation of these symptoms along with generalized weakness.Patient stated that her dizziness worsened with position changes and stated the room felt like it was spinning.Laboratory findings were relatively unremarkable.Chest x-ray along with ct abdomen/pelvis did not show any acute etiologies for nausea/vomiting.A brain mri was obtained that demonstrated an unruptured 7 mm saccular anterior communicating artery aneurysm.Two days after admission, patient underwent balloon assisted coiling of acom aneurysm.Post op, patient was admitted to the icu for close neurological monitoring/continuation of cares.Two days after balloon assisted coiling, patient underwent stent assisted coiling given small residual acom aneurysm at lobulated base.
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
No additional information regarding the event received.

• Brand Name: HYDROSOFT-3D-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: 22128815
• Report Number: 2032493-2025-90216
• Device Sequence Number: 8371435
• Product Code: KRD
• UDI-Device Identifier: 00816777025388
• UDI-Public: (01)00816777025388(11)241017(17)290930(10)0000734622
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 7110-0204
• Device Lot Number: 0000734622
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2024
• 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: HYDROSOFT 3D 7110-0202, LOT # 0000823183.; HYDROSOFT 3D 7110-0204, LOT # 0000781902.; SCEPTER XC BALLOON.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 111 KG