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

Model Number	45-751632
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records 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 coil was implanted in the patient and the remainder of the device was discarded at the user facility; therefore, a product analysis could not be performed.The root cause is unknown.The device was used during the same procedure as was reported in mfr report# 2032493-2018-00283.The instructions for use (ifu) identifies premature of difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during the treatment of a hypogastric artery, the coil did not detach with the controller.2-3 additional attempts were made to detach the coil with the controller; however, the coil did not detach.The coil was removed together with the catheter as a single unit from the destination sheath.Upon inspection of the devices after removal, it was noted that a piece of the coil remained inside the sheath.The detached coil segment was pushed out of the sheath into the hypogastric artery and covered with a gore limb extension endoprosthesis.There was no reported patient injury.The patient was reported to be stable.

• 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: 8196811
• Report Number: 2032493-2018-00284
• Device Sequence Number: 1721551
• Product Code: KRD
• UDI-Device Identifier: 00812636021096
• UDI-Public: (01)00812636021096(11)180418(17)230331(10)18041853G
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K151358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2023
• Device Model Number: 45-751632
• Device Lot Number: 18041853G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention