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

Review of the approved device history records indicated the lot met all release criteria.A lot history trending review indicated there are no other complaints 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 a very tortuous vessel, the physician attempted to use a 20cm x 50cm framing coil.A 4fr glidecath 100cm was placed for access.Resistance was encountered upon advancement through tortuosity.The coil was reported to detach in the catheter upon positioning.The coil and catheter were removed together as a system.A new system was placed and the procedure was successful.No patient injury 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: 6070922
• MDR Text Key: 58925988
• Report Number: 2032493-2016-00252
• 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