MAUDE Adverse Event Report: MICROVENTION, INC. AZUR; Device, Vascular, for Promoting Embolization

Model Number	45-780308-02
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
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 instructions for use identifies premature coil separation as a potential complication associated with use of the device.The device was stated to be available for return to the manufacturer, but it 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 report will be submitted.
Event or Problem Description
It was reported that during a vascular embolization, the practitioner used an embolization coil implant that released unexpectedly inside the patient, without activation of the detachment system.It was subsequently retrieved using a snare.Consequently, another coil of the same reference and lot number was used, and the procedure was successfully completed.There was also reported to be an increase in operating time of approximately 45 minutes.

• 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 ; 7146516118
• MDR Report Key: 25850690
• Report Number: 2032493-2026-08077
• Device Sequence Number: 5444125
• Product Code: KRD
• UDI-Device Identifier: 00842429119174
• UDI-Public: (01)00842429119174(11)251222(17)301130(10)0001498633
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 45-780308-02
• Device Lot Number: 0001498633
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/14/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2026
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 07/16/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown