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

Model Number 45-480310-L

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

The lot number was provided.A review of the approved device history record indicated that the lot met all release criteria.The device was not returned for evaluation; therefore, a product analysis could not be performed.The root cause cannot be determined.

Event Description

It was reported that during positioning of an embolization coil in a splenic pseudo aneurysm, resistance was encountered and the coil unexpectedly detached from the pusher wire.The detached distal coil segment was retrieved with a snare device.There was no reported patient injury and the patient was reported to be stable.

• Brand Name: AZUR 18 PERIPHERAL V-TRAK SYSTEM
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: debby callahan ; 1311 valencia avenue; tustin, CA 92780 ; 7142478000
• MDR Report Key: 6470871
• MDR Text Key: 72089482
• Report Number: 2032493-2017-00083
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00810170017889
• UDI-Public: (01)00810170017889(11)161114(17)211031(10)161114LC3
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2021
• Device Model Number: 45-480310-L
• Device Lot Number: 161114LC3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2016
• 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