MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX DETACHABLE; EMBOLIZATION COIL

Model Number	45-751632
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	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history record indicated the lot met all release criteria.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 for analysis.
Event or Problem Description
It was reported that during the embolization treatment for a splenic artery aneurysm, the coil was not forming to the satisfaction of the physician.During retraction of the coil to reposition it, the implant coil detached in the catheter, with 1/2 of the coil in the catheter and 1/2 of the coil in the artery.Both segments were removed in their entirety together with the catheter from the patient.There was no reported intervention or patient injury.

• Brand Name: AZUR CX DETACHABLE
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7866827
• Report Number: 2032493-2018-00182
• Device Sequence Number: 19317362
• Product Code: KRD
• UDI-Device Identifier: 00812636021096
• UDI-Public: (01)00812636021096(11)180305(17)230228(10)180305556
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 08/13/2018

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: 02/28/2023
• Device Model Number: 45-751632
• Device Lot Number: 180305556
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR