MAUDE Adverse Event Report: MICROVENTION, INC WEB SL; INTRASACCULAR DEVICES

Model Number W4-7-4-MVI

Device Problem Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2023

Event Type  malfunction  

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 returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

Event Description

It was reported that during treatment of a acom aneurysm using a web, the device detachment was unsuccessful using multiple detachment controllers.Following repeated attempts, the web detached.No patient harm or injury was reported.

Event Description

It was reported that : " a via 21 catheter was used to implant a web 7x4 into an acom aneurysm.The procedure went fine until the detachment.The wdc-2 showed a red light when connection was made with the gold connector of the web.After fiddling the light turned green and the physician tried to detach the web.Unfortunately the web did not detach.The physician tried multiple times however the web did not detach.At this point i decided to use a different wdc-2.Same problem occurred.After multiple tries this one was able to detach the web.The delivery wire and both wdc-2 will be sent back for investigation.".

Manufacturer Narrative

The investigation of the returned web system revealed a broken connector at the hypotube to connector junction.As a result, subsequent investigations were unable to proceed, and the alleged product issue remains unverified.However, the examination of the returned components did uncover that the heater coil pet showed signs of activation from a detachment controller, which corresponds to the reported complaint.Nevertheless, without conducting continuity and resistance testing, it was not possible to determine the specific conditions or circumstances that caused the issue during the physical evaluation of the device.Two web detachment controllers were also returned but found to function within specification.

• Brand Name: WEB SL
• Type of Device: INTRASACCULAR DEVICES
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 17438568
• MDR Text Key: 320220025
• Report Number: 2032493-2023-00872
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102305
• UDI-Public: (01)00842429102305(11)191119(17)241031(10)19111956
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W4-7-4-MVI
• Device Lot Number: 19111956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1