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

Model Number	45-450820
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2017
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 device was has not yet been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during positioning of an azur embolization coil, the coil unexpectedly detached without use of the controller.The coil was retrieved with a snare device.The patient was implanted with other azur coils successfully, without further incident.There was no reported patient injury.
Additional Manufacturer Narrative
The device was returned with the snare for analysis; however, the pusher was not returned.The implant coil exhibits damage from kinking at the middle segment, where the coil was in contact with the snare.The monofilament knot was noted to be intact.No other anomalies were identified.Based on the available information and evaluation of the pusher, the investigation is inconclusive, as the entire device was not available for analysis.The root cause cannot be determined.

• Brand Name: AZUR DETACHABLE 35 SYSTEMS
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6416043
• Report Number: 2032493-2017-00068
• Device Sequence Number: 36953
• Product Code: KRD
• UDI-Device Identifier: 00810170014956
• UDI-Public: (01)00810170014956(11)151008(17)201008(10)15100812
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2017

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: Physician
• Device Expiration Date: 10/08/2020
• Device Model Number: 45-450820
• Device Catalogue Number: 45-450820
• Device Lot Number: 15100812
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/17/2017
• Supplement Date Received by Manufacturer: 02/17/2017
• Initial Report FDA Received Date: 03/18/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention