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

Model Number	45-751019
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a right hepatic vein and portal vein embolization procedure, the physician hubbed the coil catheter into the 4fr glidecath and inserted the coil pusher wire into the catheter.He then noticed that there was no coil attached under xray while still inside the glidecath.He pulled the pusher wire out and confirmed that there was no coil attached to the pusher wire and there were no coils inside the body.It is assumed the coil was never attached to the pusher wire, and was not pre-maturely detached, therefore no coil was ever located.The procedure was successfully completed by proceeding to implant additional azur cx coils.There was no patient injury.
Additional Manufacturer Narrative
The physical device was not available for evaluation to investigate if a condition existed that would have contributed to the reported event.Supplemental imaging was also not provided for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation further examine the cause of the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were the presence of any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform an analysis of the device, this investigation cannot identify with certainty any potential root causes.Batch review: 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.Complaint system review: based on a review of the last 2 years of complaint data, and at the time of this investigation, no systemic issues have been identified for this batch number that would have caused or contributed to the reported event.Ifu review (additional information can be found in the ifu): potential complications: potential complications include, but are not limited to: hematoma at the site of entry, vessel/aneurysm perforation, unintended parent artery occlusion, incomplete filling, vascular thrombosis, hemorrhage, ischemia, vasospasm, edema, coil migration or misplacement, premature or difficult coil detachment, clot formation, revascularization, post-embolization syndrome, and neurological deficits including stroke and possibly death.The physician should be aware of these complications and instruct patients when indicated.Appropriate patient management should be considered.Warnings and precautions do not advance the delivery pusher with excessive force.Determine the cause of any unusual resistance, remove the azur system, and check for damage.Preparation of the azur system for delivery 12.Remove the azur detachment controller from its protective packaging.Pull the white pull-tab from the side of the detachment controller.Discard the pull-tab and place the detachment controller in the sterile field.The azur detachment controller is packaged separately as a sterile device.Do not use any power source other than the azur detachment controller to detach the coil.The azur detachment controller is intended to be used on one patient.Do not attempt to re-sterilize or otherwise re-use the azur detachment controller.13.Prior to using the device, remove the proximal end of the delivery pusher from the packaging hoop.Use care to avoid contaminating this end of the delivery pusher with foreign substances such as blood or contrast.Firmly insert the proximal end of the delivery pusher into the funnel section of the azur detachment controller.Do not push the detachment button at this time.14.Wait three seconds and observe the indicator light on the detachment controller.If the green light does not appear or if a red light appears, replace the device.If the light turns green, then turns off at any time during the three-second observation, replace the device.If the green light remains solid green for the entire three-second observation, continue using the device.15.Hold the device just distal to the shrink-lock and pull the shrink-lock proximally to expose the tab on introducer sheath.16.Slowly advance the coil out of the introducer sheath and inspect the coil for any irregularities or damage.If any damage to the coil or delivery pusher is observed, do not use the device.

• 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: 24225010
• Report Number: 2032493-2026-00045
• Device Sequence Number: 8579521
• Product Code: KRD
• UDI-Device Identifier: 00812636021072
• UDI-Public: 00812636021072
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/30/2026

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: 45-751019
• Device Catalogue Number: 45-751019
• Device Lot Number: 0000628585
• Was Device Available for Evaluation?: No
• 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: 01/05/2026
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 4FR GLIDECATH.
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White