MAUDE Adverse Event Report: MICROVENTION INC. AZUR CX 18D-LONGER; VASCULAR PROMOTING EMBOLIZATION DEVICE

Model Number	45-780204-L
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a coil embolization procedure, the coil could not advance past the distal part of the microcatheter.When the physician attempted to remove the coil, it prematurely detached.The coil was able to be pushed into the vessel using an alternative coil pusher wire.The procedure was completed successfully.The patient's condition and outcome were not affected.
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 implanted in the patient and not returned to the manufacturer for evaluation.The pusher portion of the device was stated to be available for return to the manufacturer for evaluation but has not yet been returned.The alleged product issue could not be confirmed.If any portion of the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
See h10.
Additional Manufacturer Narrative
The investigation of the returned coil system found the pusher returned without the implant attached but no indications of activation using a detachment controller on the pusher heater coil was observed.Further inspection found the pusher core wire to be kinked at the distal section.The implant was not returned for evaluation as it was delivered safely as described in the reported event.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 pusher damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: AZUR CX 18D-LONGER
• Common Device Name: VASCULAR PROMOTING EMBOLIZATION DEVICE
• 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: 18871698
• Report Number: 2032493-2024-00206
• Device Sequence Number: 20816916
• Product Code: KRD
• UDI-Device Identifier: 00816777024374
• UDI-Public: (01)00816777024374(11)230224(17)280131(10)0000328628
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162524
• 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): 04/03/2024

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: 45-780204-L
• Device Lot Number: 0000328628
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2023
• 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 Sex: Unknown