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

Model Number	45-480620-L
Medical Device Problem Codes	Detachment Of Device Component (1104); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2016
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 for analysis.The implant and delivery pusher were detached on the returned device.Under visual inspection under a microscope, there were no visible issues with the implant that would cause it to become stuck during advancement.The body coil, overcoil, and hydrogel all appeared to have no issues.The proximal end of the implant coil was stretched which was likely caused by retracting the device out of the catheter, as written in the complaint description.The pusher was also inspected under a microscope and no visible issues were detected.Based on the reported complaint and evaluation of the returned product, the root cause cannot be determined.Although the proximal end of the coil was stretched and damaged, no visible issues could be detected on the returned implant or delivery pusher which could cause the device to become stuck inside of the 2.7f microcatheter.
Event or Problem Description
It was reported that the coil got stuck in the microcatheter during advancement of an embolization coil to the intended area.The coil was then "pushed hard" to advance the coil; however, resistance was encountered.During retraction of the coil, the coil unexpectedly detached in the microcatheter.Both segments of the coil were removed in their entirety with the microcatheter.There was no reported patient injury.

• 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: 6847345
• Report Number: 2032493-2017-00227
• Device Sequence Number: 1430155
• Product Code: KRD
• UDI-Device Identifier: 00810170017957
• UDI-Public: (01)00810170017957(11)151125(17)201125(10)151125L8
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/08/2017

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: 11/25/2020
• Device Model Number: 45-480620-L
• Device Catalogue Number: 45-480620
• Device Lot Number: 151125L8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 83