MAUDE Adverse Event Report: MICROVENTION, INC. WEB SLS; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number	W5-6-4-MVI-3
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2002
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a web device would not load into the microcatheter.It was determined that the web's size was different from the size on the device's label.There was no patient involvement.
Additional 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 investigation of the returned web system found the delivery system kinked between the hypotube and connector and the implant to be the incorrect size, which is consistent with the alleged product issue.The carton box and pouch label reference a web sl 6mm x 4mm; however, the returned implant dimensional specifications match that of a 9mm sls web.This issue is tracked by quality.The physical evaluation of the device could not identify the conditions or circumstances that led to the delivery system damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: WEB SLS
• Common Device Name: INTRASACCULAR FLOW DISRUPTION DEVICE
• 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: 15324642
• Report Number: 2032493-2022-00340
• Device Sequence Number: 5293165
• Product Code: OPR
• UDI-Device Identifier: 00842429110898
• UDI-Public: (01)00842429110898(11)210218(17)240131(10)21021813Y
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: W5-6-4-MVI-3
• Device Catalogue Number: W5-6-4
• Device Lot Number: 21021813Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male