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

Model Number	45-751324
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: left internal iliac embolization using a 6fr rdc destination sheath and a 4fr c2 glidecath.This was the final coil of the case, where we were trying to put one more coil in the inflow of the aneurysm.We lost catheter position, and when we went to retract the coil before repositioning the coil stretched and detached.We tried to put negative pressure on the catheter and pull it out without success.The only path forward was to snare the coil and pull it out, which was done successfully.No patient injury was reported and the case was completed in regular fashion.
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for evaluation, but has not yet been returned despite attempts made.Additional due diligence attempts are ongoing.The alleged product issue/event as described 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-conformance's 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
No new information received.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant coil stretched at the proximal section and separated from the pusher.The pusher was not returned for evaluation.The investigation found that 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 implant, but this condition is consistent with the device experiencing forces exceeding the implant's yield strength.The catheter used in the procedure was not returned, so the investigation could not determine if it had caused or contributed to the reported complaint.

• 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: 23764577
• Report Number: 2032493-2025-90696
• Device Sequence Number: 18558806
• Product Code: KRD
• UDI-Device Identifier: 00812636021089
• UDI-Public: (01)00812636021089(11)240819(17)290731(10)0000681981
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 45-751324
• Device Lot Number: 0000681981
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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 C2 GLIDECATH.; 6FR DESTINATION SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown