MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-18 DETACHABLE HYDRO; ARTIFICIAL EMBOLIZATION DEVICE

Model Number 45-480410-L

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

Visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Procedure and medical imaging was not provided for this investigation.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were 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 and 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: there are no similar complaints based on the complaint category regarding this batch number from the last two years recorded in the complaint system at the time of this investigation.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.13.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.14.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.15.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.16.Hold the device just distal to the shrink-lock and pull the shrink-lock proximally to expose the tab on introducer sheath.17.Slowly advance the coil implant 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.H3 other text : device discarded by user/ facility.

Event Description

It was reported, upon opening the coil during the case, there was not a coil on the pusher wire.There was no patient interaction.

• Brand Name: AZUR-18 DETACHABLE HYDRO
• Type of Device: ARTIFICIAL EMBOLIZATION DEVICE
• 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: 18358477
• MDR Text Key: 331203907
• Report Number: 2032493-2023-01129
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00810170017902
• UDI-Public: (01)00810170017902(11)220217(17)270131(10)0000160097
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45-480410-L
• Device Lot Number: 0000160097
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1