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

Model Number	FGA21154-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/16/2020
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.
Event or Problem Description
It was reported that treatment was performed for a ruptured pericallosal artery bifurcation aneurysm.The via was tracked through a vessel that was reported to have a 90-degree angle coursing a short a1 segment to get to the neck of the aneurysm.The first web selected for the aneurysm was too large, so it was removed through the via without incident; however, the via was not in the proper location for placement of the smaller web and needed to be tracked back up.After successful deployment of the web in the aneurysm, a slight "dissection" was noted in subsequent angiograms at the location of the 90-degree angle in the vessel.After waiting approximately five (5) minutes, additional angiograms were taken and the physician was satisfied with the results.No additional intervention was performed.There was no reported sequela.

• Brand Name: VIA-21 MICROCATHETER-US VIA-21-154-01FOR US
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): SEQUENT MEDICAL, INC; 11 a columbia; aliso viejo, ca
• MDR Report Key: 10411605
• Report Number: 2032493-2020-00206
• Device Sequence Number: 19382907
• Product Code: DQY
• UDI-Device Identifier: 00851566003918
• UDI-Public: (01)00851566003918(11)190923(17)221031(10)19092326
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 07/16/2020

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: 10/31/2022
• Device Model Number: FGA21154-01
• Device Catalogue Number: FGA21154-01
• Device Lot Number: 19092326
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 08/14/2020
• 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: Other