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

Model Number	45-782040-L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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 discarded at the user facility; therefore, a device analysis could not be performed and the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during a peripheral coil embolization procedure, the coil would not advance and detached in the microcatheter.The coil was removed in its entirety from the patient without additional intervention.

• Brand Name: AZUR CX 18D-LONGER
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10932475
• Report Number: 2032493-2020-00356
• Device Sequence Number: 19495410
• Product Code: KRD
• UDI-Device Identifier: 00810170018404
• UDI-Public: (01)00810170018404(11)180713(17)230630(10)1807135W3
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2020

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: Other
• Device Expiration Date: 06/30/2023
• Device Model Number: 45-782040-L
• Device Catalogue Number: 45-782040
• Device Lot Number: 1807135W3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1