MAUDE Adverse Event Report: MICROVENTION, INC. COSMOS-10-AV; DEVICE NEUROVASCULAR EMBOLIZATION

Model Number	8210-0933-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, when the coil was placed into the aneurysm, it was attempted to be detached.When they pulled the pusher wire out after detachment, they realized that only half of the coil was detached.The remaining proximal half of the coil remained attached to the pusher wire, while the distal half was in the aneurysm.They proceeded to coil with competitive coils.Procedure was successful and there was no patient harm or injury reported.
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 was stated to be available for return to the manufacturer for evaluation, but has not yet been returned.The alleged product issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Additional Manufacturer Narrative
Investigation conclusion: the investigation of the returned coil system found the pusher bodycoil stretched and broken at the distal section, which is consistent with the condition of the device described in the reported event.The portion of the pusher distal to the break site and the implant were not returned for evaluation.Further investigation found the pusher's monofilament exhibited a mushroom shape, which indicates the implant did separate from the pusher from thermal activation using a detachment controller.The physical evaluation of the device could not identify the conditions or circumstances that led to the stretched and broken pusher, but the damage is consistent with the device experiencing forces exceeding the pusher's tensile strength.The microcatheter used in the procedure was not returned for evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.
Event or Problem Description
No additional incident information was received; however the evaluation of the returned device is completed.Please see h6 & h11.

• Brand Name: COSMOS-10-AV
• Common Device Name: DEVICE NEUROVASCULAR EMBOLIZATION
• 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: 23625120
• Report Number: 2032493-2025-90670
• Device Sequence Number: 18644698
• Product Code: HCG
• UDI-Device Identifier: 00816777021939
• UDI-Public: 00816777021939
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093919
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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: 8210-0933-A2
• Device Lot Number: 0000316871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 11/22/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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 Sex: Unknown