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

Model Number	45-780204-02
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a prostate artery embolization procedure, the customer opened package and flushed the hoop which holds the azur cx coil system.When the customer tried to remove the coil from the hoop, the pusher wire came out, but the sheath/housing that the distal pusher wire and coil are in did not come out of the hoop.Only the pusher wire with no coil attached came out.The customer then opened another azur cx coil, and it was successfully removed from hoop and deployed.The patient is reported to be stable.
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 returned to the manufacturer for analysis and the investigation ongoing.Upon completion of the investigation, a supplemental mdr report will be submitted.
Event or Problem Description
Please see section h11 for device investigation results.
Additional Manufacturer Narrative
Investigation conclusion: the investigation of the returned coil system found the implant and introducer stuck inside the dispenser hoop, which is consistent with the alleged product issue.The introducer remaining in the dispenser hoop is consistent with the shrink lock not being in the correct location at the time the coil was attempted to be removed.Further inspection found the pusher's monofilament with a tensile break shape at the tip, which is consistent with the device experiencing forces exceeding the tensile strength of the monofilament, causing the implant to separate from the pusher.

• 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: 24592902
• Report Number: 2032493-2026-00163
• Device Sequence Number: 18501835
• Product Code: KRD
• UDI-Device Identifier: 00842429119150
• UDI-Public: (01)00842429119150(11)251127(17)301031(10)0001470008
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 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): 04/21/2026

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: 45-780204-02
• Device Lot Number: 0001470008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2026
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2025
• 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: PROGREAT 2.4F MICROCATHETER.
• Patient Sex: Unknown