MAUDE Adverse Event Report: MICROVENTION, INC. AZUR DETACHABLE FRAMING COIL; EMBOLIZATION COIL

Model Number 45-680820

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2019

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 has not been returned to the manufacturer; therefore, a product analysis could not be performed.The device was used in the same procedure as was reported on mfr.Report number 2032493-2019-00063.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.

Event Description

It was reported that resistance was encountered during advancement of the coil in the catheter.During removal, the coil detached inside the catheter.The coil was removed in its entirety together with the catheter.There was no reported patient injury or intervention.The patient was reported to be stable.

• Brand Name: AZUR DETACHABLE FRAMING COIL
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: debby callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 8445502
• MDR Text Key: 139700932
• Report Number: 2032493-2019-00064
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00810170017742
• UDI-Public: (01)00810170017742(11)170724(17)220630(10)17072453J
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K050954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Model Number: 45-680820
• Device Catalogue Number: 45-680820
• Device Lot Number: 17072453J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2017
• 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