MAUDE Adverse Event Report: MICROVENTION, INC. TRAXCESS 14 SELECT; GUIDE WIRE

Model Number	GW1420040S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	03/31/2017
Type of Reportable Event	Death
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; therefore, a product analysis could not be performed.There was no reported device malfunction.The root cause cannot be determined.The instructions for use (ifu) identifies vessel perforation, intracerebral hemorrhage, and death as potential complications associated with use of the device.Additionally, the ifu warns to manipulate the guidewire under fluoroscopic guidance.
Event or Problem Description
It was reported that during embolization treatment of an aneurysm, "the doctor punched an artery" and a hemorrhagic event was observed a few seconds after.It was reported that the x-ray didn't work while the wire was advanced.The patient was reported to have died.No further information has been provided.

• Brand Name: TRAXCESS 14 SELECT
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6632837
• Report Number: 2032493-2017-00139
• Device Sequence Number: 19019347
• Product Code: MOF
• UDI-Device Identifier: 00812636022260
• UDI-Public: (01)00812636022260(11)161111(17)191031(10)16111130
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K133725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2017

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?: No
• Operator of Device: Other
• Device Expiration Date: 10/31/2019
• Device Model Number: GW1420040S
• Device Lot Number: 16111130
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 06/10/2017
• 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: Death