MAUDE Adverse Event Report: MICROVENTION, INC TRAXCESS 14 GUIDEWIRE (14 IN.); CATHETER, GUIDE WIRE

Model Number	GW1420040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history record and shipping inspection report of the involved product/lot# combination confirmed that no deviation or nonconformity related to the event was found.The device was not returned to the manufacturer for evaluation.The root cause cannot be determined.
Event or Problem Description
It was reported that during passage of the guide wire through a p1 occlusion, there was a possible wire perforation of a thalamoperforating branch proximally at the level of the occlusion.There was no reported additional intervention or sequela.

• Brand Name: TRAXCESS 14 GUIDEWIRE (14 IN.)
• Common Device Name: CATHETER, GUIDE WIRE
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10439786
• Report Number: 2032493-2020-00225
• Device Sequence Number: 7083982
• Product Code: MOF
• UDI-Device Identifier: 00810170012280
• UDI-Public: (01)00810170012280(11)200108(17)221231(10)200108
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/23/2020

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: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: GW1420040
• Device Catalogue Number: GW1420040
• Device Lot Number: 200108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/21/2020
• 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