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

Model Number	45-780308-L
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
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.A search for non-conformance's 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.
Event or Problem Description
It was reported that there was difficulty during the coil release and the coil was not implanted in the correct location.The coil was located in the catheter, which was able to be removed.During the procedure, other coils from the same lot were successfully implanted using the same detachment handle.There was no patient injury reported.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant damaged and deformed; however, the implant was found to be attached to the pusher upon receipt.Further inspection found the pusher returned knotted with the lead wires separated and broken.Due to the broken lead wires, the investigation could not test the continuity or resistance of the delivery system's circuit to determine if a condition existed that would have contributed to the detachment issue described in the reported event and therefore, this complaint is considered non-verifiable.The physical evaluation of the device could not identify the conditions or circumstances that led to the implant damage, but the damage is consistent with the device experiencing forces exceeding the implant's yield strength.The physical evaluation of the device could not identify the conditions or circumstances that led to the knotted pusher and broken lead wires, but the damage is consistent with the device experiencing forces exceeding the pusher's yield strength and lead wires tensile.The controller used in the procedure was not returned for evaluation, so the investigation could not determine if it had caused or contributed to the reported detachment issue.
Event or Problem Description
It was reported that there was difficulty during the coil release and the coil was not implanted in the correct location.The coil was located in the catheter, which was able to be removed.During the procedure, other coils from the same lot were successfully implanted using the same detachment handle.There was no patient injury reported.

• 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: 24016497
• Report Number: 2032493-2026-00009
• Device Sequence Number: 9191389
• Product Code: KRD
• UDI-Device Identifier: 00816777024398
• UDI-Public: (01)00816777024398(11)250305(17)300228(10)0001027688
• 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): 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): 03/31/2026

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: 45-780308-L
• Device Lot Number: 0001027688
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2025
• 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
• Patient Sex: Unknown