MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 35 CX DETACHABLE 6MM X 9CM; VASCULAR EMBOLIZATION DEVICE

Model Number	45-750609
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2020
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 and the alleged product issue could not be confirmed.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 coil embolization was attempted in a splenic artery.The anatomy was very tortuous and it was difficult for the coil to navigate the vessel.After several attempts to manipulate and reposition the coil, the pusher wire detached inside the catheter.Both segments of the coil were removed in their entirety together with the catheter.There was no patient injury or additional intervention.The patient was reported to be "fine.".

• Brand Name: AZUR 35 CX DETACHABLE 6MM X 9CM
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10497928
• Report Number: 2032493-2020-00245
• Device Sequence Number: 2344407
• Product Code: KRD
• UDI-Device Identifier: 00812636021034
• UDI-Public: (01)00812636021034(11)190507(17)240430(10)1905075K2
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151358
• 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): 08/07/2020

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: 04/30/2024
• Device Model Number: 45-750609
• Device Catalogue Number: 45-750609
• Device Lot Number: 1905075K2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 09/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1