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

Model Number	45-480810
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2018
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 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 the treatment of a vascular malformation in the lower leg, the coil got stuck and then detached in the catheter.Both segments of the coil were removed in their entirety along with the catheter from the patient.There was no reported patient injury or intervention.
Additional Manufacturer Narrative
The device was returned with the pusher and catheter for analysis.The catheter demonstrated signs of kinks on the gold connector section, close to the epoxy joints.The pusher appeared to be in specification, with slights folding in the strain relief section.The pusher was dissected to expose the attachment tether monofilament.The monofilament displayed a stretched tail.Based upon the investigation analysis and available information, the reported complaint is confirmed.The root cause of the break is unknown.The monofilament tail and stretched coils on the implant are indicative of a tensile break, which can be caused by user applying too much force during the procedure.

• 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: 8097875
• Report Number: 2032493-2018-00251
• Device Sequence Number: 16641060
• Product Code: HCG
• UDI-Device Identifier: 00810170017964
• UDI-Public: (01)00810170017964(11)170215(17)220131(10)170215LC2
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2018

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: 01/31/2022
• Device Model Number: 45-480810
• Device Catalogue Number: 45-480810
• Device Lot Number: 170215LC2
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1