MAUDE Adverse Event Report: MICROVENTION, INC. AZUR; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	45-880050
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: was told that the coil detached prematurely.Doctor ended up having to use a snare to remove the coil.
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for evaluation, but has not yet been returned despite attempts made.Additional due diligence attempts are ongoing.The alleged product issue/event as described 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.
Event or Problem Description
There was no harm to patient.The procedure was successful.They were able to complete case utilizing more coils.
Additional Manufacturer Narrative
Additional information received, see b5.Describe event or problem.The investigation found the implant coil returned separated from the pusher and partially stuck within the catheter.The implant coil was also found stretched at the proximal section and entangled.The pusher was not returned for evaluation.The investigation found the implant's monofilament with a tensile break shape at the tip which is consistent with the device experiencing force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the stretched implant, but the damage is consistent with the device experiencing forces exceeding the implant's yield strength.The returned catheter was found kinked at approximately 29cm from the hub tip, which may have caused or contributed to the reported complaint.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.

• Brand Name: AZUR
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING 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: 24599062
• Report Number: 2032493-2026-00164
• Device Sequence Number: 9499938
• Product Code: KRD
• UDI-Device Identifier: 00842429118078
• UDI-Public: (01)00842429118078(11)250731(17)300630(10)0001213112
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K223050
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 45-880050
• Device Lot Number: 0001213112
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 04/12/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 2.4 PROGREAT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown