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

Model Number	45-751324
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The device was stated to be available for return to the manufacturer for evaluation.It has not been returned to the manufacturer.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 report will be submitted.
Event or Problem Description
It was reported that an embolization coil implant had to be positioned several times.The coil became stuck and would not advance out of the catheter.During retraction of the coil, the coil became stuck and then unexpectedly detached from the pusher.The coil was withdrawn in its entirety along with the microcatheter.There was no injury or intervention.
Additional Manufacturer Narrative
Items returned for evaluation: pusher; implant; introducer; non-terumo neuro catheter.The visual analysis of the returned device found that the implant was not attached to the pusher.The implant was returned stretched at the proximal section, separated from the pusher, and partially stuck within the returned catheter.The returned catheter was found to be flattened at 13cm from the strain relief.The investigation of the pusher found the monofilament broken, which indicates that the device experienced a tensile break.The investigation of the returned coil system found the implant stretched at the proximal section, separated from the pusher, and partially stuck within the returned catheter; however, no indications of thermal 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 damage, but the damage is consistent with the device experiencing forces over specification.The catheter used in the procedure was found to be flattened at 13cm from the strain relief, which may have caused or contributed to the reported complaint.
Event or Problem Description
It was reported that an embolization coil implant had to be positioned several times.The coil became stuck and would not advance out of the catheter.During retraction of the coil, the coil became stuck and then unexpectedly detached from the pusher.The coil was withdrawn in its entirety along with the microcatheter.There was no injury or intervention.

• 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
• MDR Report Key: 20242874
• Report Number: 2032493-2024-00692
• Device Sequence Number: 17970114
• Product Code: KRD
• UDI-Device Identifier: 00812636021089
• UDI-Public: 00812636021089
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/28/2024

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: 45-751324
• Device Catalogue Number: 45-751324
• Device Lot Number: 0000631892
• 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: 08/30/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2024
• 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
• Patient Sex: Unknown