MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 HYDROCOIL DETACHABLE 2MM X 2CM; VASCULAR EMBOLIZATION DEVICE

Model Number	45-480202
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	03/12/2020
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 returned to the manufacturer for evaluation.The investigation is underway.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 an embolization coil unexpectedly detached without use of the controller.There was no reported patient injury or additional intervention.
Additional Manufacturer Narrative
All components of the device were received.The implant was still attached to the pusher with no evidence of thermal detachment.The implant and the over-coil on the implant were damaged.The distal portion of the pusher, the core wire, was kinked.The pusher's electrical resistance was measured at 40.4 ohms, which is within specification.The proximal connector resistance was measured at "ol," which is normal.The 4-way v-grip continuity test indicated all green lights.The tip was undamaged.Based on the investigation, the complaint is unconfirmed because the implant was found still attached to the pusher and had not prematurely detached.

• Brand Name: AZUR 18 HYDROCOIL DETACHABLE 2MM X 2CM
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9960273
• Report Number: 2032493-2020-00100
• Device Sequence Number: 16747940
• Product Code: KRD
• UDI-Device Identifier: 00810170017841
• UDI-Public: (01)00810170017841(11)191031(17)240930(10)1910315JB
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K111451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

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: Other
• Device Expiration Date: 09/30/2024
• Device Model Number: 45-480202
• Device Catalogue Number: 45-480202
• Device Lot Number: 1910315JB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1