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

Model Number	45-880035
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Reduced Blood Flow (4598)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded at the user facility and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.The event as described could not be confirmed.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
It was reported that coil deployment was going well until the vessel tapered down to about a 1.5mm.After that, the coil would not form.Due to retracting and re-advancing, the coil detached within microcatheter.The physician reported that the broken coil embolized to the spleen, causing a minor infarction.Everything was removed and the physician snared the coil in the splenic artery.The patient outcome was reported as stable.

• 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: 23069174
• Report Number: 2032493-2025-90494
• Device Sequence Number: 9680676
• Product Code: KRD
• UDI-Device Identifier: 00842429118061
• UDI-Public: 00842429118061
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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: 45-880035
• Was Device Available for Evaluation?: No
• 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: 08/28/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: COMPETITOR MICROCATHETER, 2.8 X 130.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown