MAUDE Adverse Event Report: MICROVENTION, INC. VIA MICROCATHETER; CATHETER, PERCUTANEOUS

Model Number	VIA-17-154-01-AL
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Aneurysm (1708); Intracranial Hemorrhage (1891); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Items returned: - n/a visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Procedure and medical imaging were not provided for this investigation.Investigation findings: without the return and physical evaluation of the device, the investigation cannot further examine if a condition existed that would have contributed to the reported event.Without imaging, the investigation cannot further verify if the event occurred as described, nor could the investigation further evaluate the cause of the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were the presence of any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform an analysis of the device, this investigation cannot identify with certainty any potential root causes.Batch review: 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.Complaint system review: based on a review of the last 2 years of complaint data, and at the time of this investigation, no systemic issues have been identified for this batch number that would have caused or contributed to the reported event.Ifu review (additional information can be found in the ifu): potential complications.Potential complications include but are not limited to the following: hematoma at the site of entry, aneurysm rupture, emboli, vessel perforation, parent artery occlusion, hemorrhage, ischemia, vasospasm, vascular thrombosis and neurological deficits including stroke and death.Warnings: never advance or withdraw a device against resistance until the cause of the resistance is determined by fluoroscopy.Excessive force against resistance may result in damage to the device or vessel perforation.When injecting contrast for angiography, ensure the catheter is not kinked or occluded.Do not exceed 300 psi maximum recommended infusion pressure.Excess pressure may result in catheter damage or patient injury.Steam shaping may result in improper device delivery and deployment, depending on the degree of shaping and catheter deflection during device delivery.Using the via microcatheter with guide catheters smaller than what is recommended may result in damaging the hydrophilic coating.Precautions: the via microcatheter has a lubricious hydrophilic coating on the outside of the catheter.It must be kept hydrated in order to be lubricious.This can be accomplished by attaching a y-connector to a continuous saline drip.The operator should be aware that microcatheters, in distal blood vessels, may increase the risk of thromboemboli.Procedure catheterization of the lesion 5.Prepare an appropriately sized guidewire and insert into the microcatheter per the manufacturer¿s instructions.6.Introduce the guidewire and microcatheter as a unit into the guiding catheter until the distal tip of the guide catheter has been reached.Alternatively advance the guidewire and microcatheter until the desired site has been reached.Verify catheter position using fluoroscopy.7.After the microcatheter has been positioned inside the lesion, remove the guidewire.8.Flush the id of the microcatheter with sterile flush solution by attaching a syringe to the catheter hub 9.Attach a second rhv to the hub of the microcatheter.Attach a one-way stopcock to the sidearm of the second rhv and connect the flush solution line to the stopcock.10.Open the stopcock to allow flush through the microcatheter with sterile flush solution.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
It was reported that while moving the web device in the via microcatheter, it was noted under fluoroscopy that the via had moved through the aneurysm and the patient was hemorrhaging.The web was immediately removed from the microcatheter, and three balt optima coils were placed to control the bleeding.Post procedure showed blood in the brain and the patient status is unknown at the time of reporting.The rep was not informed of any further surgery performed after the case.One day post procedure, the patient was doing better than expected and able to move without any paralysis.The patient did stop talking earlier on 19jun2025.The scans were reported as unchanged.The patient presented with a ruptured aca with bleeding that had subsided prior to the case.The patient was under conscious sedation and was moving.The patient was experiencing vasospasm in the a1 segment and therefore, the physician administered verapamil.A balt ballast catheter 90cm, sofia 5f 115cm, a traxcess ex wire, and a web 17 4 x 2 were used along with the via 17.The via 17 was parked just past the neck of the aneurysm and the web was prepped in bowl and pre-test was successfully performed with the wdc.The web was inserted into the via and fluoroscopy was started.It was immediately noted that the via had moved through the aneurysm and there was hemorrhaging.The territory sales manager was present for the case.The devices were discarded by the user facility.It was reported that six days prior to hospitalization, the patient complained of headache and then worsening of speech occurred on (b)(6) 2025.The patient was then taken to the hospital.

• Brand Name: VIA MICROCATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 22494946
• Report Number: 2032493-2025-90318
• Device Sequence Number: 4235196
• Product Code: DQY
• UDI-Device Identifier: 00842429118702
• UDI-Public: (01)00842429118702(11)250308(17)280229(10)0001028601
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K192135
• 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): 07/14/2025

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: VIA-17-154-01-AL
• Device Lot Number: 0001028601
• 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: 06/18/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALT OPTIMA COILS X 3; WEB LOT # 0000256878
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Male