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

Model Number FGA15090-040

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2019

Event Type  malfunction  

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 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
• Type of Device: WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM
• 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: 8952735
• MDR Text Key: 156285740
• Report Number: 2032493-2019-00203
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00856956005985
• UDI-Public: (01)00856956005985(11)190529(17)240608(10)19052950
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170032
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FGA15090-040
• Device Catalogue Number: FGA15090-040
• Device Lot Number: 19052950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2019
• 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
• Patient Age: 52 YR