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

Model Number	45-481220
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Additional 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 with implant stuck inside of the catheter for analysis.The returned catheter was noted to have kinks and a tear.The implant was twisted, and the over coil was compressed and accumulated at a certain section of the coil.Resistance was encountered during an attempt to remove the coil from the catheter.The coil was noted to be stretched.Based on the available information and evaluation of the returned device, the complaint can be confirmed.The root cause cannot be determined; however, the device exhibits 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.
Event or Problem Description
It was reported that while advancing an embolization coil, the coil detached in the microcatheter.The hydrogel coil swelled in the microcatheter and was stuck, so the coil was removed in its entirety along with the microcatheter from the patient.There was no reported intervention or patient injury.The patient is reported to be good.

• Brand Name: AZUR 18 PERIPHERAL V-TRAK SYSTEM
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7801833
• Report Number: 2032493-2018-00165
• Device Sequence Number: 1249628
• Product Code: HCG
• UDI-Device Identifier: 00810170018039
• UDI-Public: (01)00810170018039(11)170216(17)220131(10)170216LC2
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K090168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2018

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
• Operator of Device: Other
• Device Expiration Date: 01/31/2022
• Device Model Number: 45-481220
• Device Catalogue Number: 45-481220
• Device Lot Number: 170216LC2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1