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

Model Number	45-480310
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult to Remove (1528); Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
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 currently underway.
Event or Problem Description
It was reported that during placement of the third embolization coil in the right gastric artery, the coil did not detach.During removal, the coil detached.The detached coil was successfully removed with a snare device.There was no reported patient injury.The patient was reported to be stable.
Additional Manufacturer Narrative
The device was returned detached from the pusher.The pusher was noted to have numerous kinks along its length, and around different locations.The distal section of the heater coil appeared to be in good condition, with no burn marks on the strain relief.The implant appeared to be in good condition, with no kinks or damage.The resistance of the system measured to be within specification; however, was intermittent.The solder connections were checked on both the distal and proximal sections; both sections appeared to be in good condition.The pusher was dissected on the distal end to expose the attachment tether monofilament.The tether tip had a somewhat straight cut, with a thin stretched tail.Based on the reported details and investigation findings, the complaint could be confirmed.The exact root cause is unknown; however, the damage to the device exhibited evidence that it was subjected to excessive tensile force that exceeded its maximum strength specification.

• 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: 7599274
• Report Number: 2032493-2018-00113
• Device Sequence Number: 1623920
• Product Code: HCG
• UDI-Device Identifier: 00810170017889
• UDI-Public: (01)00810170017889(11)170428(17)220331(10)17042854Z
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: 45-480310
• Device Catalogue Number: 45-480310
• Device Lot Number: 17042854Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention