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

Model Number	45-750812
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2017
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 delivery pusher was returned for evaluation.The implant coil was not attached to the pusher.No damage was observed on the delivery pusher.The monofilament was visible within the distal segment, near the heater coil.One fluoroscopic image was provided and reviewed.The image confirms a stretched proximal coil.Based on the information provided, a definitive root cause cannot be determined.
Event or Problem Description
It was reported that while attempting to pull the azur coil back, it was noted that the coil had become detached in the catheter.The coil was pushed with a 3cc syringe with saline.At that time it was noted that part of the coil wire was still attached to the coil.An attempt was made to retrieve the coil with a snare device, but it was unsuccessful and the coil was left behind.The patient's current status is reported to be fine.

• Brand Name: AZUR CX 35 DETACHABLE
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6452437
• Report Number: 2032493-2017-00080
• Device Sequence Number: 10909616
• Product Code: KRD
• UDI-Device Identifier: 00812636021058
• UDI-Public: (01)00812636021058(11)160418(17)210418(10)16041811
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2017

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: 04/18/2021
• Device Model Number: 45-750812
• Device Lot Number: 16041811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2017
• Initial Report FDA Received Date: 04/02/2017
• 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
• Patient Age: 62 YR
• Patient Weight: 102