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	Hemorrhage, Cerebral (1889); Perforation of Vessels (2135)
Date of Event	03/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was not provided; therefore, the device history records could not be reviewed.The device was discarded at the user facility and not returned for evaluation; therefore, a product analysis could not be performed.The root cause cannot be determined.The instructions for use (ifu) identifies vessel perforation and intracerebral hemorrhage as potential complications associated with use of the device.
Event or Problem Description
It was reported that during treatment for spasmolysis in the right internal carotid artery (ica), the wire perforated the ica, resulting in interhemispherical bleeding above the corpus callosum.The patient was reported to be on ass and plavix (dual antiplatelet therapy) due to recent implantation of a flow diverter in the ica.No intervention was performed to address the bleeding at the time of the procedure.The patient remains ventilated and cannot breathe alone; it is unclear how long the patient will need assisted ventilation.At this time, it is unknown if the patient has sustained any permanent injury or impairment.

• Brand Name: TRAXCESS 14 SELECT
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6514322
• Report Number: 2032493-2017-00098
• Device Sequence Number: 1627010
• Product Code: MOF
• UDI-Device Identifier: 00812636022260
• UDI-Public: (01)00812636022260(11)161108(17)191031(10)16110825
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/31/2019
• Device Model Number: GW1420040S
• Device Lot Number: 16110825
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2017
• Initial Report FDA Received Date: 04/22/2017
• 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: Hospitalization; Life Threatening
• Patient Age: 60 YR