MAUDE Adverse Event Report: SEQUENT MEDICAL, INC WEB SINGLE LAYER-USA W2-9-4; WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM

Model Number	FGA15090-040
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.The manufacturing records were reviewed.All inspection values were within specification and there were no ncr's or deviations.The device was not returned for evaluation; therefore, an analysis could not be conducted.The root cause cannot be determined.
Event or Problem Description
It was reported that a web device was successfully detached within an aneurysm, but the pusher wire was advanced forward, invaginating the web device and pushing it closer to the dome of the aneuysm.A snare was used to pull the web back into place.There was no reported adverse clinical sequela to the patient.

• Brand Name: WEB SINGLE LAYER-USA W2-9-4
• Common Device Name: WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM
• Manufacturer (Section D): SEQUENT MEDICAL, INC; 11 a columbia; aliso viejo CA 92656
• MDR Report Key: 8952735
• Report Number: 2032493-2019-00203
• Device Sequence Number: 14071216
• Product Code: OPR
• UDI-Device Identifier: 00856956005985
• UDI-Public: (01)00856956005985(11)190529(17)240608(10)19052950
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2019

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/08/2024
• Device Model Number: FGA15090-040
• Device Catalogue Number: FGA15090-040
• Device Lot Number: 19052950
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/30/2019
• 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
• Patient Age: 52 YR