MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 18D-LONGER; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	45-780308-L
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Difficult to Advance (2920); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2025
Type of Reportable Event	Serious Injury
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 stated to be available for return to the manufacturer for evaluation but has not yet been returned.The alleged product issue 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.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
As reported, during coil embolization of a branch of the right external carotid artery feeding an oropharyngeal tumor in the interventional radiology room, medical team members introduced the embolization coil into the microcatheter.A premature fragmentation of the coil support was then observed, manifested by a separation of the support wire into three distinct branches before any deployment or release of the device.This abnormal disintegration, which occurred when the coil was only inserted and not yet deployed, prevented the normal progress of the procedure.The coil was removed and use of another.No clinical consequences for the patient.
Additional Manufacturer Narrative
Based on clarifying incident information received from the reporter, there was no coil detachment malfunction.The leadwires of the delivery pusher became loose however, remained attached.Therefore, microvention no longer considers this event a reportable malfunction event.
Event or Problem Description
Additional clarifying information was received which indicated that the coil did not prematurely detach or migrate from the delivery pusher however, the leadwires of the delivery pusher became loose at the proximal end while remaining attached to the delivery pusher."as the coil was pushed into the microcatheter, the staff felt the support wire come loose, preventing the coil from advancing.The coil was removed and use of another.No clinical consequences for the patient".

• Brand Name: AZUR CX 18D-LONGER
• 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: 22172919
• Report Number: 2032493-2025-90241
• Device Sequence Number: 18492106
• Product Code: KRD
• UDI-Device Identifier: 00816777024398
• UDI-Public: (01)00816777024398(11)231125(17)281031(10)0000468327
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K12384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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: 45-780308-L
• Device Lot Number: 0000468327
• Was Device Available for Evaluation?: Yes
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/17/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown