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

Model Number	45-480420
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	01/17/2019
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 has been returned to the manufacturer.The investigation is underway.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 during a gastroduodenal artery embolization treatment for a gastrointestinal bleed, the coil detached inside the catheter.The coil was removed in its entirety along with the catheter.There was no reported patient injury or intervention.The patient was reported to be stable.
Additional Manufacturer Narrative
The device was returned with the pusher for analysis.Investigation of the pusher found the proximal end to be damaged.The proximal connector was found to be kinked.The proximal solder joints were found to be intact.The attachment bond was found to be solid and intact.The distal end of the coil was without damage, and did not display signs of a thermal detachment.The attachment tether was found to have rebounded.026." the tether was wavy inside the body of the pusher.The distal end of the monofilament did not exhibit a profile to that definitively represented stretching or thermal detachment.Based on the investigation findings and available information, the reported complaint is confirmed, as the implant was found to be detached from the pusher upon return.The root cause cannot be definitively determined, but is suspected to be the result of tensile forces that exceed the specification of the device.It is unknown as to whether the implant was being advanced or retracted when the detachment occurred.The wavy nature of the tether is indicative of excessive stretching of the material, which could occur during retraction of a implant that is stuck in a microcatheter.The microcatheter and implant were not returned preventing further analysis.

• 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: 8346202
• Report Number: 2032493-2019-00029
• Device Sequence Number: 1915830
• Product Code: HCG
• UDI-Device Identifier: 00810170017926
• UDI-Public: (01)00810170017926(11)171108(17)221031(10)17110851Q
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 01/18/2019

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
• Operator of Device: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: 45-480420
• Device Catalogue Number: 45-480420
• Device Lot Number: 17110851Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1