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

Model Number	W5-4-2
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
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 device has been returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
As reported: device was tested prior to insertion with green light.Device inserted into mca aneurysm and when going to detach, it was flashing green and then red.Tried a new detacher and went through proper cycle, but no clear deflection.Went to use the microcatheter to push the device off and it resheathed.Since it resheathed back into microcatheter, decided to remove device entirely.New device successfully placed.Good result, good patient outcome.
Event or Problem Description
No additional information received regarding the event.
Additional Manufacturer Narrative
The investigation of the returned web system found the pusher hypotube kinked at the middle section and the proximal connector kinked at the brown lead wire joint.The unit did not pass continuity and resistance testing.Further inspection of the pusher found the black lead wire broken at the distal solder joint, which is consistent with non-detachment.The physical evaluation of the device could not identify the conditions or circumstances that led to the pusher kinks, but the damage is consistent with the device experiencing forces exceeding the pusher's yield strength.The physical evaluation of the device could not identify the conditions or circumstances that led to the broken black lead wire, but the damage is consistent with the device experiencing forces exceeding the solder joint's tensile strength.The returned wdc-2 controller was found to function as intended and would not have contributed to the reported event.

• Brand Name: WEB SL
• 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: 23619393
• Report Number: 2032493-2025-90667
• Device Sequence Number: 18664588
• Product Code: OPR
• UDI-Device Identifier: 00842429110812
• UDI-Public: (01)00842429110812(11)250218(17)280131(10)0000923361
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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: W5-4-2
• Device Lot Number: 0000923361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VIA MICROCATHETER.; WDC-2.
• Patient Age: 64 YR
• Patient Sex: Male