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

Model Number	GW1420040
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	04/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to the manufacturer for analysis.The details of the event were forwarded to terumo, the actual device manufacturer.A supplemental report with the results of their investigation and device history records search will be submitted when their investigation is complete.
Event or Problem Description
It was reported that a patient who had a coiling procedure performed later developed foreign body related vasculitis some months after the procedure.Filamentous components from foreign objects could be verified, but not the real origin; a traxcess guidewire was one of many devices used during the procedure.It was stated that the filamentous components showed "basophil characteristics" and a casual relationship between the vasculitis and the traxcess could not be verified.The patient is reported to be doing "ok.".
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The actual device was not returned for analysis; therefore, a product evaluation could not be performed and a casual relationship between the vasculitis and the traxcess could not be verified.

• Brand Name: TRAXCESS 14 GUIDEWIRE (14 IN.)
• Common Device Name: CATHETER, GUIDE WIRE
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12584565
• Report Number: 2032493-2021-00396
• Device Sequence Number: 17043580
• Product Code: MOF
• UDI-Device Identifier: 00810170012280
• UDI-Public: (01)00810170012280(11)201124(17)231031(10)201124
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K133725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2021

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: 10/31/2023
• Device Model Number: GW1420040
• Device Catalogue Number: GW1420040
• Device Lot Number: 201124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Unknown