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

Model Number	45-780413-L
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an embolization coil implant would not deploy.The coil was positioned but the physician decided to remove and resheath it to reposition his microcatheter.Upon removal the physician noted that the coil had detached.The coil was close to where the physician wanted it to be, just not packed appropriately.There was no negative impact from the coil detaching early and before the physician wanted it.The procedure was successful, not prolonged, and the patient had an uneventful recovery.
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-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.
Additional Manufacturer Narrative
The investigation of the returned coil system found the pusher returned without the implant attached but no indications of activation using a detachment controller was found on the pusher heater coil.The implant was not returned for evaluation.Further inspection found the pusher to be kinked with lead wire separation at the proximal section.The investigation found the pusher¿s monofilament with a tensile break shape at the tip, which is consistent with the device experiencing force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the pusher kink, but the damage is consistent with the device experiencing forces exceeding the pusher's yield strength.The microcatheter used in the procedure was not returned, so the investigation could not determine if it had caused or contributed to the reported complaint.
Event or Problem Description
It was reported that an embolization coil implant would not deploy.The coil was positioned but the physician decided to remove and resheath it to reposition his microcatheter.Upon removal the physician noted that the coil had detached.The coil was close to where the physician wanted it to be, just not packed appropriately.There was no negative impact from the coil detaching early and before the physician wanted it.The procedure was successful, not prolonged, and the patient had an uneventful recovery.

• Brand Name: AZUR CX 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: 23559783
• Report Number: 2032493-2025-90651
• Device Sequence Number: 21369599
• Product Code: KRD
• UDI-Device Identifier: 00810170018299
• UDI-Public: 00810170018299
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 12/29/2025

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: 45-780413-L
• Device Catalogue Number: 45-780413
• Device Lot Number: 0000698552
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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