MAUDE Adverse Event Report: SEQUENT MEDICAL, INC WEB LOW PROFILE SL-USA W4-6-5FOR US; WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM, PRODUCT

Model Number FGA25060-050

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rupture (2208)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer; therefore, an analysis could not be performed.The root cause cannot be determined.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 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 # 2032493-2019-00226.

Event Description

It was reported that during treatment of a middle cerebral artery aneurysm, the microcatheter ruptured the dome of the aneurysm.A web device was being advanced through the microcatheter at the time.The patient was treated with balloon remodeling and six embolization coils.After extubation, the patient was reported to have no cognitive impairment and was moving both sides of the body.

• Brand Name: WEB LOW PROFILE SL-USA W4-6-5FOR US
• Type of Device: WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM, PRODUCT
• 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: 9091608
• MDR Text Key: 159310680
• Report Number: 2032493-2019-00228
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00854111006112
• UDI-Public: (01)00854111006112(11)190329(17)220417(10)19032908
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170023
• 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: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/17/2022
• Device Model Number: FGA25060-050
• Device Catalogue Number: FGA25060-050
• Device Lot Number: 19032908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2019
• 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): Life Threatening; Required Intervention