MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 HYDROCOIL DETACHABLE 5MM X 20CM; VASCULAR EMBOLIZATION DEVICE

Model Number	45-480520-L
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	12/23/2019
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 has not been returned to the manufacturer for evaluation.The root cause cannot be determined.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 an embolization coil implant unexpectedly detached without use of the controller.A snare device was used to remove the coil from the patient.There was no patient injury.

• Brand Name: AZUR 18 HYDROCOIL DETACHABLE 5MM X 20CM
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9625250
• Report Number: 2032493-2020-00011
• Device Sequence Number: 18936950
• Product Code: HCG
• UDI-Device Identifier: 00812636020501
• UDI-Public: (01)00812636020501(11)151029(17)201029(10)151029LC2
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/26/2019

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: Other
• Device Expiration Date: 10/29/2020
• Device Model Number: 45-480520-L
• Device Catalogue Number: 45-480520
• Device Lot Number: 151029LC2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 01/24/2020
• 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
• Patient Age: 65 YR
• Patient Weight: 62