MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 35 HYDROCOIL DETACHABLE 15MM X 20CM; VASCULAR EMBOLIZATION DEVICE

Model Number	45-451520
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2020
Type of Reportable Event	Serious Injury
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 returned to the manufacturer for evaluation.The root cause could not be established.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.The submission of this report or related information to the fda, and its release by the 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 coil unexpectedly detached.The coil was retrieved with a snare device.There was no additional intervention or reported patient injury.

• Brand Name: AZUR 35 HYDROCOIL DETACHABLE 15MM X 20CM
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9803201
• Report Number: 2032493-2020-00068
• Device Sequence Number: 779056
• Product Code: KRD
• UDI-Device Identifier: 00810170015014
• UDI-Public: (01)00810170015014(11)180530(17)230430(10)18053052N
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 45-451520
• Device Catalogue Number: 45-451520
• Device Lot Number: 18053052N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention