MAUDE Adverse Event Report: MICROVENTION, INC. AZUR DETACHABLE 35 SYSTEMS; EMBOLIZATION COIL

Model Number	45-452030
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2019
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 was not available for return to the manufacturer.Therefore, the root cause could not be established.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report or the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.
Event or Problem Description
It was reported that an embolization implant coil became detached prematurely during the procedure.There was no reported patient injury or intervention.

• Brand Name: AZUR DETACHABLE 35 SYSTEMS
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9132206
• Report Number: 2032493-2019-00233
• Device Sequence Number: 3122875
• Product Code: KRD
• UDI-Device Identifier: 00810170015045
• UDI-Public: (01)00810170015045(11)190207(17)240131(10)19020753B
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K093002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2019

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: 01/31/2024
• Device Model Number: 45-452030
• Device Catalogue Number: 45-452030
• Device Lot Number: 19020753B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1