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

Model Number	45-750824
Medical Device Problem Codes	Unraveled Material (1664); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
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-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 right femoral access to the left internal iliac embolization target 100cm 4fr straight glidecath was used with guidesheath support to cannulate the internal iliac.An azur 8x24 35cx coil was prepped properly and introduced and tracked to the target.Approximately a third of the coil was deployed past the delivery catheter.When the operator attempted to pull back on the pusher wire and the coil did not move.It was determined that the coil had detached on its own.Upon further investigation it was determined that the coil was somehow still attached to something.They inspected the pusher wire on the field and realized it separated more proximal from where the coil was actually detached.It appeared as if the pusher wire pulled apart and was now a spiral string.The operator was able to remove the delivery catheter and grab the pusher wire with stats and removed the coil.There was no patient injury.The operator successfully deployed the following cx35 8x12 8x12 6x17 coils.
Event or Problem Description
It was reported that the right femoral access to the left internal iliac embolization target 100cm 4fr straight glidecath was used with guidesheath support to cannulate the internal iliac.An azur 8x24 35cx coil was prepped properly and introduced and tracked to the target.Approximately a third of the coil was deployed past the delivery catheter.When the operator attempted to pull back on the pusher wire and the coil did not move.It was determined that the coil had detached on its own.Upon further investigation it was determined that the coil was somehow still attached to something.They inspected the pusher wire on the field and realized it separated more proximal from where the coil was actually detached.It appeared as if the pusher wire pulled apart and was now a spiral string.The operator was able to remove the delivery catheter and grab the pusher wire with stats and removed the coil.There was no patient injury.The operator successfully deployed the following cx35 8x12 6x17 coils.
Additional Manufacturer Narrative
The investigation of the returned coil system found the pusher strain relief damaged, and the implant coil stretched at the proximal section and separated from the pusher.No indications of activation using a detachment controller were observed on the pusher's heater coil.The investigation found the pusher¿s monofilament with 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.However, the investigation did not observe any stretched or broken conditions on the returned pusher proximal to the detachment zone as described in the reported event.The physical evaluation of the device could not identify the conditions or circumstances that led to the strain relief damage and the stretched implant, but this damage is consistent with the device experiencing forces exceeding the pusher and implant's yield strength.The catheter used in the procedure was not returned for evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.

• 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: 24300144
• Report Number: 2032493-2026-00072
• Device Sequence Number: 9397431
• Product Code: KRD
• UDI-Device Identifier: 00812636021065
• UDI-Public: 00812636021065
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 45-750824
• Device Catalogue Number: 45-750824
• Device Lot Number: 0000820788
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2024
• 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: UNKNOWN MICROCATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown