MAUDE Adverse Event Report: SEQUENT MEDICAL, INC VIA-21 MICROCATHETER-US VIA-21-154-01FOR US

Model Number	FGA21154-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage, Subarachnoid (1893); Rupture (2208)
Date of Event	11/20/2019
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 was not returned for evaluation.The root cause cannot be determined.The instructions for use (ifu) identifies rupture as a potential complication associated with the use of this device.
Event or Problem Description
It was reported that while treating a middle cerebral artery bifurcating aneurysm with a web device, the aneurysm was ruptured with a guidewire and a via 21 microcatheter during attempts to access the aneurysm prior to the introduction of the web.The case was terminated at that point.
Additional Manufacturer Narrative
Clarifying details of the event were provided.It was reported that the guide wire (not a microvention device) was introduced in the aneurysm and the via was advanced over the guide wire into the aneurysm.During retraction of the guide wire, the via jumped forward.The aneurysm ruptured and a subarachnoid hemorrhage was stabilized shortly afterward by the neurosurgeon.At the time of the event, the patient remained stable.The patient is reported to be alive.
Additional Manufacturer Narrative
Additional information was received on 2/12/2020: after the aneurysm rupture, the patient was stabilized in the angio suite and the bleed was stopped by a partially deployed coil.The patient was then taken to the operating room and the aneurysm was treated.

• Brand Name: VIA-21 MICROCATHETER-US VIA-21-154-01FOR US
• Common Device Name: MICROCATHETER
• Manufacturer (Section D): SEQUENT MEDICAL, INC; 11 a columbia; aliso viejo CA 92656
• MDR Report Key: 9507914
• Report Number: 2032493-2019-00296
• Device Sequence Number: 16604025
• Product Code: DQY
• UDI-Device Identifier: 00851566003918
• UDI-Public: (01)00851566003918(11)190812(17)220930(10)19081212
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2019

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: Other
• Device Expiration Date: 09/30/2022
• Device Model Number: FGA21154-01
• Device Catalogue Number: FGA21154-01
• Device Lot Number: 19081212
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 01/13/2020; 02/12/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 02/12/2020; 02/19/2020
• 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: Life Threatening