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

Model Number	45-750812
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	09/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The device was not returned to the manufacturer for analysis.Therefore, 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 a coil embolization procedure, the coil implant detached prematurely.A snare was used to retrieve the detached coil.There was no reported patient injury.
Additional Manufacturer Narrative
The dispenser hoop, pusher, and implant were all returned for evaluation.The introducer and microcatheter were not returned.The implant was found detached from the pusher.The heater coil of the pusher did not hvae any evidence of thermal detachment.The distal uv glue joint for the outer sleeve was broken.The pusher core wire and the gold connector were both bent.The electrical resistance of the pusher was found to be in specification.The implant was stretched at the proximal end.The attachment monofilament was dissected out from the pusher and the tip was found to be somewhat stretched.The monofilament's condition indicates the implant most likely experienced a pulling force over specification, which caused it to stretch and detach from the pusher.The origin of the force placed on the device could not be determined.

• 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: 9227094
• Report Number: 2032493-2019-00247
• Device Sequence Number: 14080814
• Product Code: KRD
• UDI-Device Identifier: 00812636021058
• UDI-Public: (01)00812636021058(11)181204(17)231130(10)18120455N
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151358
• 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): 09/26/2019

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: 11/30/2023
• Device Model Number: 45-750812
• Device Catalogue Number: 45-750812
• Device Lot Number: 18120455N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 11/27/2019
• 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