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

Model Number	45-650820
Medical Device Problem Codes	Detachment Of Device Component (1104); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2016
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 for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that resistance was encountered during advancement of an embolization coil in the microcatheter.The coil was then "pushed hard" to advance the coil, and the coil unexpectedly detached.There was no reported patient injury.The patient is reported to be fine.
Additional Manufacturer Narrative
The implant coil was returned for evaluation; however, the pusher was not returned.The implant coil was noted to be intact and separated from the pusher, and kinked along the full length.The proximal section of the coil was noted to be significantly kinked.The proximal knot-tie was intact on implant, and the laser weld ball was present.Based on the investigation, the complaint of coil detachment was not confirmed, as the implant coil was found damaged, stretched, and separated from the pusher, but not detached.The reported event details indicate the coil was pushed hard after it met resistance during advancement, which could have resulted in the damage to the device, although the root cause for the initial resistance could not be determined.The instructions for use (ifu) warns "do not advance the delivery pusher with excessive force.Determine the cause of any unusual resistance, remove the azur -dsystem, and check for damage.Advance and retract the azur -dsystem device slowly and smoothly.Remove the entire azur-d system if excessive friction is noted.".

• Brand Name: AZUR DETACHABLE FRAMING COIL
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 6819652
• Report Number: 2032493-2017-00212
• Device Sequence Number: 19190060
• Product Code: KRD
• UDI-Device Identifier: 00810170016097
• UDI-Public: (01)00810170016097(11)160125(17)210125(10)160125JC2
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2017

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: Physician
• Device Expiration Date: 01/25/2021
• Device Model Number: 45-650820
• Device Catalogue Number: 45-650820
• Device Lot Number: 160125JC2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/27/2017
• Supplement Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1