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

Model Number	45-451230
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	10/16/2018
Type of Reportable Event	Malfunction
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 device has been returned to the manufacturer.The investigation is underway.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 an embolization treatment, the coil detached without use of the controller.Both segments of the coil were removed in their entirety along with the catheter from the patient.There was no reported patient injury or intervention.
Additional Manufacturer Narrative
The implant was returned for analysis.The pusher was not returned.The implant did not have the monofilament.The overcoil was noted to be stretched.The gel was broken; however, the unit was exposed to blood and the sterilization process, which could affect the condition of the gel.Based upon the investigation analysis and available information, the reported complaint is inconclusive.The investigation was limited with only the implant returned, and exposure to blood and sterilization, which may have contributed to the condition of the returned device.The root cause is unknown, as there is not enough information to determinate the correlation and complete the evaluation.

• 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: 8097847
• Report Number: 2032493-2018-00252
• Device Sequence Number: 2178842
• Product Code: KRD
• UDI-Device Identifier: 00810170015007
• UDI-Public: (01)00810170015007(11)180119(17)221231(10)180119556
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2018

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: 12/31/2022
• Device Model Number: 45-451230
• Device Catalogue Number: 45-451230
• Device Lot Number: 180119556
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1