MAUDE Adverse Event Report: MICROVENTION, INC. VIA-17 MICROCATHETER; PERCUTANEOUS CATHETER

Model Number	VIA-17-154-01-MVI2
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	08/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance's 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 discarded at the user facility and not returned to the manufacturer for evaluation.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use (ifu) identifies aneurysm rupture as a potential complication associated with use of the device.
Event or Problem Description
It was reported that a patient with a ruptured mca aneurysm was treated with a web device.The physician placed a via 17 microcatheter in the middle of the aneurysm and removed the guidewire.The physician then advanced the web through the via 17 under fluoroscopy.During advancement, the via 17 moved and went through the dome of the aneurysm at the rupture site.The physician then placed the web device in the aneurysm.The patient is reported to be "doing very well and will be discharged soon." there was no reported intervention.

• Brand Name: VIA-17 MICROCATHETER
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12523232
• Report Number: 2032493-2021-00388
• Device Sequence Number: 5159574
• Product Code: DQY
• UDI-Device Identifier: 00842429106402
• UDI-Public: (01)00842429106402(11)210312(17)240229(10)21031211V
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2021

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 Expiration Date: 02/29/2024
• Device Model Number: VIA-17-154-01-MVI2
• Device Catalogue Number: VIA-17-154-01
• Device Lot Number: 21031211V
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other