MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-35 DETACH PLATINUM; EMBOLIZATION COIL

Model Number 45-652050

Device Problems Fracture (1260); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2016

Event Type  malfunction  

Manufacturer Narrative

A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there is one similar complaint reported for this lot number.The device was not returned to the manufacturer; therefore, an evaluation could not be performed.Based on the information provided, the root cause of this complaint cannot be determined.

Event Description

It was reported that during the treatment of a splenic aneurysm with very tortuous vasculature, a 4fr glidecatheter 100cm was used to access.During positioning/placement of the embolization coil, the coil separated from the delivery pusher.The device was removed successfully without removing the glidecatheter.A new system was used to complete the case successfully.No patient injury was reported.

• Brand Name: AZUR-35 DETACH PLATINUM
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: eva manus ; 1311 valencia avenue; tustin, CA 92780 ; 7142478000
• MDR Report Key: 6070966
• MDR Text Key: 58932918
• Report Number: 2032493-2016-00264
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/29/2020
• Device Model Number: 45-652050
• Device Lot Number: 15082910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2015
• 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