MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 PERIPHERAL V-TRAK SYSTEM; EMBOLIZATION COIL

Model Number 45-480520

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2019

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.The device was reported to be infectious and discarded at the user facility; therefore, a product analysis could not be performed.The root cause cannot be determined.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.

Event Description

It was reported that the 4th embolization coil could not be placed into the coil pack at the intended treatment site.During removal, the coil detached in the microcatheter.There was no reported patient injury or intervention.The patient was reported to be stable.

• Brand Name: AZUR 18 PERIPHERAL V-TRAK SYSTEM
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: debby callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 8547639
• MDR Text Key: 143040861
• Report Number: 2032493-2019-00111
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00812636020501
• UDI-Public: (01)00812636020501(11)150903(17)200903(10)150903L8
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2019

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
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Model Number: 45-480520
• Device Catalogue Number: 45-480520
• Device Lot Number: 150903L8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2019
• Initial Date FDA Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2015
• 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
• Patient Age: 38 YR
• Patient Weight: 75