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

Model Number	45-480610
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	10/23/2018
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 discarded at the user facility and not returned to the manufacturer for review; therefore, a product analysis could not be performed.The root cause is unknown.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 the coil detached without the use of the detachment controller.The coil was removed in its entirety along with the microcatheter.There was no reported patient injury or intervention.The patient was reported to be stable.
Additional Manufacturer Narrative
The implant coil was returned for analysis.The implant was not stretched or damaged, and the monofilament was attached correctly to the implant coil.The proximal section of the implant had the monofilament section detached, and the monofilament had a mushroom shape, which is indicative of a thermal detachment.However without the missing components limited the investigation, because it is not possible to conduct an evaluation of the heater coil/detachment section.Based upon the investigation analysis and available information, the reported complaint of a detached coil without use of the controller was unverifiable.The investigation confirmed that the coil was detached; the monofilament had a mushroom shape, which is produced when the detachment controller is activated.To detach the monofilament of the heater coil section without controller intervention is possible by stretching the monofilament and breaking it; however, the returned implant and monofilament did not have any indication of stretching.The returned components indicate that the device was detached normally/thermally through the activation of the controller.The device performed as expected and within specifications.

• 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: 8087757
• Report Number: 2032493-2018-00249
• Device Sequence Number: 1599083
• Product Code: HCG
• UDI-Device Identifier: 00810170017933
• UDI-Public: (01)00810170017933(11)170717(17)220630(10)17071753J
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2018

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: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 45-480610
• Device Catalogue Number: 45-480610
• Device Lot Number: 17071753J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1