MAUDE Adverse Event Report: MICROVENTION, INC. TRAXCESS 7 MINI; GUIDE WIRE

Model Number	GW0721006M
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2017
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 returned for evaluation in its original packaging, without its introducer.Upon investigation, a section of coating came off 146cm from the distal tip.Without the synchro 2 insertion tool used in the procedure, it is unable to confirm if there were any rough edges or burs in the tool which could have caused the coating to come off.The returned guidewire was hydrated and introduced through a new traxcess introducer in which no additional coating came off.Based upon the investigation findings and available information, the reported complaint was confirmed; however, the root cause cannot be determined.
Event or Problem Description
It was reported that the traxcess guidewire was removed from the patient to re-shape the tip.Prior to re-use in the patient, the insertion tool was backloaded onto the guidewire and during the process, the coating appeared to strip off the guidewire.There was no reported patient injury.The patient's current status is reported to be stable.

• Brand Name: TRAXCESS 7 MINI
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6735039
• Report Number: 2032493-2017-00173
• Device Sequence Number: 10925953
• Product Code: MOF
• UDI-Device Identifier: 00816777025494
• UDI-Public: (01)00816777025494(11)170305(17)191031(10)17030521
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K161803
• 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
• Report Date (Section B): 06/23/2017

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: 10/31/2019
• Device Model Number: GW0721006M
• Device Lot Number: 17030521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 07/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1