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

Model Number MV-AX81238CL

Device Problems Detachment Of Device Component (1104); Uncoiled (1659)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided.A review of the approved device history records indicate the lot met all release criteria.A lot history trending review was performed and there are no similar complaints for this lot number.The device was not returned to the manufacturer; therefore, an evaluation could not be performed.The root cause is unknown.

Event Description

It was reported that as an azur embolization coil was being placed in the intended treatment site, the coil appeared to be loosely coiled and not tightly wound.The coil was withdrawn from the patient.The coil was then noted to have detached in the microcatheter.Another coil was used to complete the procedure.There was no reported intervention or patient injury.

• Brand Name: AZUR CX DETACHABLE
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: sandra valencia ; 1311 valencia avenue; tustin, CA 92780 ; 7142478000
• MDR Report Key: 6252151
• MDR Text Key: 64915200
• Report Number: 2032493-2017-00012
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 04987350988157
• UDI-Public: (01)04987350988157(11)160111(17)210111(10)16011149
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071939
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/11/2021
• Device Model Number: MV-AX81238CL
• Device Lot Number: 16011149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1