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

Model Number MV-AZ50620HD

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 02/18/2019

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.A lot history trending review was performed and there were no similar complaints for this lot number.The device was discarded at the user facility; therefore, a product analysis could not be performed.The root cause is unknown.

Event Description

It was reported that during preparation, the embolization coil detached when it was soaked in a heated 60°c saline solution.The device was not used in the patient.

• Brand Name: AZUR DETACHABLE 35 HYDROCOIL
• 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: 8441797
• MDR Text Key: 139551690
• Report Number: 2032493-2019-00062
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 04987892097591
• UDI-Public: (01)04987892097591(11)180504(17)230430(10)18050451V
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093002
• 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: 02/19/2019

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: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: MV-AZ50620HD
• Device Lot Number: 18050451V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2018
• 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