MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 HYDROCOIL DETACHABLE 5MM X 15CM; ARTIFICIAL EMBOLIZATION DEVICE

Model Number	45-480515
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2020
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 detached within the microcatheter without use of the controller.The coil was removed in its entirety together with the microcatheter.There was no reported patient injury or additional intervention.
Additional Manufacturer Narrative
The device was received with the implant detached from the delivery pusher.No sign of thermal detachment was found on the heater coils.The monofilament had a tail profile, indicating tensile forces were applied to the device.The uv glue bond on the implant and pusher body coil were measured and both met specification.The implant detached from the delivery pusher due to tensile or retraction forces that exceeded the strength of the monofilament; however, the origin of the force placed upon the monofilament cannot be determined.The microcatheter used in the procedure was not evaluated as a part of this investigation, so it could not be determined if it had caused or contributed to the reported complaint.

• Brand Name: AZUR 18 HYDROCOIL DETACHABLE 5MM X 15CM
• Common Device Name: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9742463
• Report Number: 2032493-2020-00040
• Device Sequence Number: 2483122
• Product Code: HCG
• UDI-Device Identifier: 00812636020495
• UDI-Public: (01)00812636020495(11)150910(17)200910(10)150910KC1
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2020

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: Health Professional
• Device Expiration Date: 09/10/2020
• Device Model Number: 45-480515
• Device Catalogue Number: 45-480515
• Device Lot Number: 150910KC1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1