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

Model Number FGA21154-01

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Hemorrhage, Subarachnoid (1893); Rupture (2208)

Event Date 08/15/2019

Event Type  Injury  

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; therefore, an analysis could not be conducted.The root cause cannot be determined.The instructions for use (ifu) identifies rupture as a potential complication associated with the use of this device.The device associated with this event was used during the same procedure referenced in mfr.Report # 2032493-2019-00222.

Event Description

It was reported that treatment was attempted on an anterior communicating artery aneurysm (acom) which had an acute takeoff angle from the parent artery.After multiple attempts, the microcatheter finally gained access to the aneurysm from the right internal carotid artery (ica); however, the web device was not opening adequately, despite several deployment attempts.The microcatheter and web device were removed.A new via 21 microcatheter was successful at obtaining access to the aneurysm from the left ica.Deployment of the same web device was attempted, but efforts were unsuccessful due to difficult anatomy.During partial deployment of the web, a new roadmap image was obtained, which demonstrated an aneurysm rupture with contrast extravasation.The web device was removed and the aneurysm was partially coiled through the via microcatheter, which was effective at controlling the bleeding; however, changes in the patient's vital signs were indicative of a subarachnoid hemorrhage.The aneurysm treatment was stopped at this point so that an evd could be placed.The patient was stable at the end of the procedure.The patient is reported to have recovered and the aneurysm was retreated with another endovascular procedure.

• Brand Name: VIA-21 MICROCATHETER-US VIA-21-154-01FOR US
• Type of Device: MICROCATHETER
• Manufacturer (Section D): SEQUENT MEDICAL, INC; 11 a columbia; aliso viejo CA 92656
• Manufacturer Contact: morgan holody ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 9056904
• MDR Text Key: 161548183
• Report Number: 2032493-2019-00223
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00851566003918
• UDI-Public: (01)00851566003918(11)190211(17)200331(10)19021106
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 03/31/2020
• Device Model Number: FGA21154-01
• Device Catalogue Number: FGA21154-01
• Device Lot Number: 19021106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention