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

Model Number	VIA-17-154-01-MVI2
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	05/13/2022
Type of Reportable Event	Serious Injury
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 remains implanted; 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 during treatment of the acomm aneurysm the via-17 catheter re-ruptured the aneurysm.The physician placed a scepter xc and a web device to treat the patient.The status of the patient is unknown at this time.

• Brand Name: VIA-17 MICROCATHETER
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656
• MDR Report Key: 14526091
• Report Number: 2032493-2022-00208
• Device Sequence Number: 6191082
• Product Code: DQY
• UDI-Device Identifier: 00842429106402
• UDI-Public: (01)00842429106402(11)220330(17)250228(10)0000172035
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2022

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 Expiration Date: 02/28/2025
• Device Model Number: VIA-17-154-01-MVI2
• Device Catalogue Number: VIA-17-154-01
• Device Lot Number: 0000172035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male