MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 DETACHABLE HYDRO; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	45-480204-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	04/23/2023
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 not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental mdr report.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during a coil embolization for a gi bleed, the second coil prematurely detached from the delivery pusher.The coil deployed in the correct site and stayed in place.The procedure was successful.No patient harm or injury was reported.

• Brand Name: AZUR 18 DETACHABLE HYDRO
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo 92656
• MDR Report Key: 16833149
• Report Number: 2032493-2023-00026
• Device Sequence Number: 17925266
• Product Code: KRD
• UDI-Device Identifier: 00810170017858
• UDI-Public: (01)00810170017858(11)210608(17)260531(10)2106085KB
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2023

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: 45-480204-L
• Device Catalogue Number: 45-480204
• Device Lot Number: 2106085KB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 99 KG