MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 SYSTEM HELICAL HYDROCOIL; EMBOLIZATION COIL

Model Number AZ80420HD

Device Problems Difficult To Position (1467); Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2014

Event Type  Injury  

Event Description

It was reported that upon the positioning the coil within the aneurysm, it could not be placed.Upon withdrawal, the coil prematurely detached partially within the microcatheter and the parent artery.The coil was fixed to the wall of the common iliac artery with a stent.No harm was reported.Patient info- patient identifier, age, sex, and weight are not available.

Manufacturer Narrative

Sample analysis: an evaluation of the actual complaint could not be performed as the implant coil remains within the patient and the delivery pusher was reported not available for return due to infectious exposure.The root cause of this complaint cannot be determined.

• Brand Name: AZUR 18 SYSTEM HELICAL HYDROCOIL
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; tustin CA
• Manufacturer Contact: teri halverson ; 1311 valencia; tustin, CA 92780 ; 7142478000
• MDR Report Key: 3835925
• MDR Text Key: 4406263
• Report Number: 2032493-2014-00049
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AZ80420HD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2014
• Initial Date FDA Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Required Intervention