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

Model Number	45-751019
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: dr.Inserted the azur cx.035 into the catheter for placement on a tips revision case.He stated that as he was advancing the coil, it detached from the shaft.He removed the shaft, then injected saline to force the coil out of the catheter.He then used a snare to remove the coil and as he was doing this it unraveled.He removed all products except the sheath and started over.He then placed the catheter and deployed another azur cx.035 with no issues.No patient injury was reported.
Additional Manufacturer Narrative
The device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, 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
As reported: dr.Inserted the azur cx.035 into the catheter for placement on a tips revision case.He stated that as he was advancing the coil, it detached from the shaft.He removed the shaft, then injected saline to force the coil out of the catheter.He then used a snare to remove the coil and as he was doing this it unraveled.He removed all products except the sheath and started over.He then placed the catheter and deployed another azur cx.035 with no issues.No patient injury was reported.
Additional Manufacturer Narrative
Items returned for evaluation: pusher, implant, non-terumo neuro snare device.Items not returned for evaluation: catheter.The visual analysis of the returned device found the pusher returned with no implant attached, the strain relief damaged and the outer sleeve broken at the distal end.The implant was returned stretched, separated from the pusher, and caught on a snare device.The investigation found the pusher's monofilament broken, which indicates that the device experienced a tensile break.The investigation of the returned coil system found the pusher strain relief damaged, the pusher outer sleeve broken at the distal end, and the implant stretched and separated from the pusher; however, no indications of activation using a detachment controller was found on the pusher 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.The physical evaluation of the device could not identify the conditions or circumstances that led to the implant and pusher damage, but the damage is consistent with the device experiencing forces exceeding the implant and pusher'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: 21621117
• Report Number: 2032493-2025-00227
• Device Sequence Number: 6837820
• Product Code: KRD
• UDI-Device Identifier: 00812636021072
• UDI-Public: (01)00812636021072(11)240610(17)290531(10)0000625796
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 04/10/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 45-751019
• Device Lot Number: 0000625796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2025
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• 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: COOK CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female