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

Model Number	45-480410-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	12/05/2017
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 has not been returned for evaluation.
Event or Problem Description
It was reported that resistance was encountered during advancement of the coil.During the removal attempt, the coil detached in the microcatheter.Both segments of the coil were removed together with the microcatheter from the patient.There was no reported intervention or patient injury.The patient was reported to be stable.
Additional Manufacturer Narrative
The pusher and detached implant coil were returned for analysis.The implant coil was not attached to the pusher and was stretched on the proximal end; however, the proximal tie knot and marker band were intact.The end of the monofilament was not visible on the implant.The distal tip of the pusher was intact and not kinked.The hydrogel was dehydrated with blood on the surface indicating that it was inside the catheter or vessel of the patient.Based on the investigation, the complaint could not be verified as implant coil was stretched at the proximal end and detached from the pusher.This is consistent with the attachment monofilament being subjected to tensile force greater than what was required to initiate stretching of the coil.The implant is broken detachment zone but not broken into two spate pieces.There is not enough evidence available to confirm that a premature detachment occured.

• 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: 7170288
• Report Number: 2032493-2018-00003
• Device Sequence Number: 13925867
• Product Code: HCG
• UDI-Device Identifier: 00810170017902
• UDI-Public: (01)00810170017902(11)161110(17)211031(10)161110LC5
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K050954
• 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): 12/08/2017

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: 10/31/2021
• Device Model Number: 45-480410-L
• Device Catalogue Number: 45-480410
• Device Lot Number: 161110LC5
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 03/23/2018
• 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: Other
• Patient Weight: 84