MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 35 DETACHABLE; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	45-750824
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the manufacturer and the investigation is ongoing.Upon completion of the investigation, a supplemental mdr report will be submitted.
Event or Problem Description
It was reported that the embolization coil was used in a procedure to treat an uterine fibroid embolization (ufe).The coil unintentionally detached from the pusher wire inside the microcatheter.The coil was removed from the patient and procedure completed using another coil.Closure and recovery went well with no issues to the patient who was stable.
Additional Manufacturer Narrative
Additional information: h6, h11 (device evaluation).No additional clinical information was received.Investigation conclusion: the investigation of the returned coil system found the implant stretched at the proximal end, and the pusher outer sleeve damaged at approximately 82cm from the heater coil; however, the implant coil was found to still be attached to the pusher upon receipt.The investigation of the returned device did not find any damage or other anomaly that would have caused the reported premature detachment issue.The physical evaluation of the device could not identify the conditions or circumstances that led to the stretched implant and pusher damage, but the damage is consistent with the device experiencing forces exceeding the implant and pusher's yield strength.

• Brand Name: AZUR CX 35 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: 22154206
• Report Number: 2032493-2025-90232
• Device Sequence Number: 7957641
• Product Code: KRD
• UDI-Device Identifier: 00812636021065
• UDI-Public: (01)00812636021065(11)230113(17)271231(10)0000309778
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: 45-750824
• Device Lot Number: 0000309778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• 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
• Patient Age: 43 YR
• Patient Sex: Female