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

Model Number	45-880020
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 2.4 progreat microcatheter.6 fr ansel sheath.Mustang balloon.Cx, ruby lp, embold and nester coils.V-grip: 45-4001, lot# 0001168175.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 returned to the manufacturer for analysis and the investigation ongoing.Upon completion of the investigation, a supplemental mdr report will be submitted.
Event or Problem Description
It was reported that during a splenic aneurysm embolization case, there was extreme tortuosity, the doctor was using a microcatheter with an 0.18 gt-r, the microcatheter tracked through the tortuosity easily.The provider was able to deploy multiple coils through the microcatheter.He tried to deploy a non-microvention packing coil and tried to manipulate the microcatheter while the coil was in the catheter and encountered an issue where the non-microvention coil detached prematurely.The provider was able to push that coil out, he flushed the microcatheter and performed an angiogram.He then tried to advance a 20cm hyrdopack coil and encountered resistance.He tried to remove the hydropack and the coil got stuck and broke.He removed the pusher wire and the portion that had broken, the coil started to unravel but he removed the microcatheter which had the remainder of the broken coil within it with no issues.The case finished with no other issues and the patient was able to go to recovery.
Additional Manufacturer Narrative
Investigation conclusion: the investigation of the returned coil system found the implant coil separated from the pusher, stretched, broken, and entangled, which is consistent with the alleged product issue.The pusher was not returned for evaluation.The investigation found the implant's monofilament at the tie knot showed 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 stretched and broken implant, but the damage is consistent with the device experiencing forces exceeding the implant's yield and tensile strength.
Event or Problem Description
Please see section h11 for device investigation results.

• Brand Name: AZUR
• 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: 24847338
• Report Number: 2032493-2026-00239
• Device Sequence Number: 12993453
• Product Code: KRD
• UDI-Device Identifier: 00842429118054
• UDI-Public: (01)00842429118054(11)250723(17)300630(10)0001204021
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K223050
• 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,Followup
• Report Date (Section B): 05/20/2026

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: 45-880020
• Device Lot Number: 0001204021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2026
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2025
• 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