MAUDE Adverse Event Report: MICROVENTION.INC AZUR-18 DETACHABLE HYDRO; PERIPHERAL

Model Number	45-480615-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	10/27/2022
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 remains implanted in the patient and not available for return to the manufacturer for analysis; therefore, a product analysis could not be conducted, and the reported issue cannot be confirmed.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
It was reported that during a peripheral coil embolization, the coil did not detach initially with the use of the detacher; however, the coil unintentionally detached without further attempt with the controller.The device is implanted in the patient.There was no reported patient injury or additional intervention.

• Brand Name: AZUR-18 DETACHABLE HYDRO
• Common Device Name: PERIPHERAL
• 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: 15784920
• Report Number: 2032493-2022-00523
• Device Sequence Number: 4546223
• Product Code: KRD
• UDI-Device Identifier: 00810170017940
• UDI-Public: (01)00810170017940(11)210614(17)260531(10)2106145KB
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2022

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: 05/31/2026
• Device Model Number: 45-480615-L
• Device Catalogue Number: 45-480615
• Device Lot Number: 2106145KB
• Was Device Available for Evaluation?: No
• 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: 10/28/2022
• Initial Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• 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