MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 CX DETACHABLE 6MM X 20CM; VASCULAR EMBOLIZATION DEVICE

Model Number	45-780620
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	02/28/2020
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 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.
Event or Problem Description
It was reported that after placement of an embolization coil at the intended treatment site, the coil unexpectedly detached without use of the detachment controller.The coil was properly placed and there was no additional intervention or reported patient injury.
Additional Manufacturer Narrative
Additional information: (b5) treatment was being performed on a pulmonary artery that was hemorrhaging.

• Brand Name: AZUR 18 CX DETACHABLE 6MM X 20CM
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9802941
• Report Number: 2032493-2020-00066
• Device Sequence Number: 779052
• Product Code: KRD
• UDI-Device Identifier: 00810170018312
• UDI-Public: (01)00810170018312(11)170706(17)220630(10)170706568
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: 06/30/2022
• Device Model Number: 45-780620
• Device Catalogue Number: 45-780620
• Device Lot Number: 170706568
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1