MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-35 DETACHABLE HYDRO; VASCULAR EMBOLIZATION DEVICE

Model Number	45-451530
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	10/09/2020
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 implanted in the patient and the delivery system was not returned to the manufacturer for evaluation.Therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) states: "do not advance the delivery pusher with excessive force.Determine the cause of any unusual resistance, remove the azur system, and check for damage" and "advance and retract the azur system slowly and smoothly.Remove the entire azur system if excessive friction is noted." 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 coil embolization for a varicocele, the embolization coil was advanced with additional force and the coil detached in the microcatheter.The wire was used to push the implant coil into the treatment site.There was no reported patient injury or additional intervention.

• Brand Name: AZUR-35 DETACHABLE HYDRO
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10807063
• Report Number: 2032493-2020-00325
• Device Sequence Number: 3500634
• Product Code: KRD
• UDI-Device Identifier: 00810170015021
• UDI-Public: (01)00810170015021(11)160719(17)210630(10)160719YC1
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/06/2020

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: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 45-451530
• Device Catalogue Number: 45-451530
• Device Lot Number: 160719YC1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 11/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1