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

Model Number	45-750617
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for analysis, but it 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.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.
Event or Problem Description
It was reported that the embolization coil implant detached unexpectedly.It was reported that there was no patient injury.There was a cancellation in the case.
Event or Problem Description
As reported: embolization coil implant detached unexpectedly.There was no patient injury.There was no cancellation of the case reported.
Additional Manufacturer Narrative
The investigation found the implant coil stretched and broken at the proximal section, which is consistent with the alleged product issue.The pusher and the portion of the implant proximal to the break site were not returned for evaluation.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.Correction: the age of the patient is not 12 months.It is not known.

• 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: 22866002
• Report Number: 2032493-2025-90425
• Device Sequence Number: 13096016
• Product Code: KRD
• UDI-Device Identifier: 00812636021041
• UDI-Public: 00812636021041
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 45-750617
• Device Catalogue Number: 45-750617
• Device Lot Number: 0000470628
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2023
• 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 Age: 12 MO
• Patient Sex: Unknown