MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 35 DETACHABLE; DEVICE VASCULAR FOR PROMOTING EMBOLIZATION

Model Number	45-752039
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
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.A portion of the coil system was stated to be returned.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
It was reported that during an embolization procedure, the coil was opened for use.When it was deployed, they found under x ray that there was no coil on the pusher rod.The device was removed, and it was confirmed that no coil was present.There was nothing in the hoop either.Another coil was used.The patient is fine.Additional information received stated that it is uncertain how they pretested the coil prior to insertion into the patient.However, they did hub the device to the catheter.Then, it was pushed from the back until the sheath reached the delivery pusher's gold connector, and it was removed.Once it was in, they noticed there was no coil attached to the pusher rod.Another coil was used to complete the procedure successfully.

• Brand Name: AZUR CX 35 DETACHABLE
• 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: 24405938
• Report Number: 2032493-2026-00111
• Device Sequence Number: 20888894
• Product Code: KRD
• UDI-Device Identifier: 00812636021102
• UDI-Public: (01)00812636021102(11)220713(17)270630(10)0000226937
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K151358
• 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): 05/19/2026

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: 45-752039
• Device Lot Number: 0000226937
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2022
• 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