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

Model Number	45-781238
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	03/13/2019
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.The device was not returned to the manufacturer; therefore, a product analysis could not be performed.The root cause cannot be determined.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 in the microcatheter.There was no reported patient injury or intervention.The patient was reported to be stable.
Additional Manufacturer Narrative
The pusher and implant were received for evaluation.Review of the returned implant found the implant to be in good condition, except for a minor bend in the shape.The tether was broken at the markerband location.The pusher was found to have a smashed heater coil and a sharp bend in the body of the pusher.The pusher appeared to be doubled over itself.The monofilament was removed from the pusher for further analysis.The distal end of the monofilament was found to have a tail, which historically is related to tensile forces.Based on the physical evaluation of the returned device, the reported complaint is confirmed, as the implant was returned detached from the pusher.The microcatheter was not returned, preventing complete analysis of the reported complaint.The root cause cannot be definitively determined at this time.Though it cannot be confirmed, the reported complaint is consistent with a coil/pusher that became stuck in a microcatheter and broke upon retraction.

• 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: 8525483
• Report Number: 2032493-2019-00090
• Device Sequence Number: 2689426
• Product Code: KRD
• UDI-Device Identifier: 00810170018367
• UDI-Public: (01)00810170018367(11)180619(17)230531(10)1806195W3
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123384
• 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): 03/18/2019

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: Other
• Device Expiration Date: 05/31/2023
• Device Model Number: 45-781238
• Device Catalogue Number: 45-781238
• Device Lot Number: 1806195W3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1