MAUDE Adverse Event Report: SEQUENT MEDICAL, INC. WEB LOW PROFILE SL-USA W4-6-3FOR US; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number	FGA25060-030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance 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 web was implanted and the delivery system was not returned for evaluation.The root cause cannot be determined.The instructions for use (ifu) identifies hemorrhage and vessel dissection or perforation as potential complications associated with the use of the device.
Event or Problem Description
It was reported that treatment was performed on an unruptured terminus bifurcation aneurysm in the internal carotid artery.After deployment of the web, an aneurysm rupture and slow bleed was identified.A balloon was inflated and the bleeding stopped.The patient was reported to be "awake and ok" with "no headache" approximately one hour after the procedure.The patient is currently reported to be doing "great.".

• Brand Name: WEB LOW PROFILE SL-USA W4-6-3FOR US
• Common Device Name: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): SEQUENT MEDICAL, INC.; 11 a columbia; aliso viejo, ca
• MDR Report Key: 9827495
• Report Number: 2032493-2020-00061
• Device Sequence Number: 2929654
• Product Code: OPR
• UDI-Device Identifier: 00854111006099
• UDI-Public: (01)00854111006099(11)181221(17)220122(10)18122103
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2020

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: 01/22/2022
• Device Model Number: FGA25060-030
• Device Catalogue Number: FGA25060-030
• Device Lot Number: 18122103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 03/12/2020
• 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: Required Intervention