MAUDE Adverse Event Report: MICROVENTION, INC AZUR DETACHABLE 35 SYSTEMS; EMBOLIZATION COIL

Model Number	45-450820
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	05/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.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.A lot history trending review was performed and there were no similar complaints for this lot number.The device has not been returned to the manufacturer.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during embolization of a splenic aneurysm, the coil detached from the pusher wire after approximately half of the implant coil had been placed in the aneurysm.The pusher was removed from the catheter and negative pressure was applied to the implant coil as it was removed simultaneously with the catheter from the patient.There was no reported patient injury or intervention.

• Brand Name: AZUR DETACHABLE 35 SYSTEMS
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8719297
• Report Number: 2032493-2019-00159
• Device Sequence Number: 11268167
• Product Code: KRD
• UDI-Device Identifier: 00810170014956
• UDI-Public: (01)00810170014956(11)190102(17)231231(10)190102542
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K093002
• 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): 05/24/2019

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: 12/31/2023
• Device Model Number: 45-450820
• Device Catalogue Number: 45-450820
• Device Lot Number: 190102542
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1