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

Model Number 45-480420

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

Patient Problem No Consequences Or Impact To Patient (2199)

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 returned to the manufacturer for analysis.The investigation is currently underway.

Event Description

It was reported that the coil would no longer advance through the microcatheter after the 1st coil loop had emerged from the distal tip.During the attempt to withdraw the coil back into the microcatheter, the coil detached.The detached coil was successfully pushed out of the microcatheter with the pusher wire into the intended treatment site.There was no reported patient injury or intervention.The patient is reported to be stable.

Manufacturer Narrative

The pusher was returned for evaluation.There was no damage noted in heater coil section, and the pusher was in conformance, with the exception of a small kink in the un-stretched platinum coil section.The distal end of the pusher was dissected to expose the attachment tether for analysis.A tensile break was noted on the attachment tether tip, which measured a rebound length of 0.196".Based upon the investigation findings and available information, the reported complaint can be confirmed.The root cause cannot be determined; however, the device exhibited evidence that it was subjected to tensile forces that exceeded its strength specifications.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.

• 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
• MDR Report Key: 7940395
• MDR Text Key: 123806332
• Report Number: 2032493-2018-00217
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K090168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/16/2020
• Device Model Number: 45-480420
• Device Lot Number: 150615EC1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1