MAUDE Adverse Event Report: SEQUENT MEDICAL, INC. WEB LOW PROFILE SL-USA W4-5-3FOR US; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number FGA25050-030

Device Problems Difficult or Delayed Positioning (1157); Separation Failure (2547); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2020

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 to the manufacturer for evaluation.The root cause of the complaint cannot be determined.The instructions for use (ifu) identifies device migration or misplacement, premature or difficult device detachment, and difficult detachment as potential complications associated with the use of the device.

Event Description

It was reported that treatment was performed for an acom aneurysm.After placement of the web device, detachment was initiated with the controller; however, the web moved back with the delivery wire as it was being withdrawn.Multiple attempts were made to detach the web by manipulating the device with the microcatheter, the delivery wire, and with the detachment controller.As a result of the manipulations, the proximal portion of the web herniated into the parent artery.A stent was deployed to ensure proper placement of the web in the aneurysm.There was no reported patient injury. .

• Brand Name: WEB LOW PROFILE SL-USA W4-5-3FOR US
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): SEQUENT MEDICAL, INC.; 11 a columbia; aliso viejo, ca
• Manufacturer Contact: eva manus ; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10255851
• MDR Text Key: 201238928
• Report Number: 2032493-2020-00161
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00854111006068
• UDI-Public: (01)00854111006068(11)200203(17)250131(10)20020311L
• 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: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FGA25050-030
• Device Catalogue Number: FGA25050-030
• Device Lot Number: 20020311L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2020
• 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