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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental mdr report.The instructions for use (ifu) identifies damaged coating as potential complications associated with use of the device.
Event or Problem Description
It was reported that during treatment of a stroke on a left media artery, a second and third pass were necessary to catch the clot.During the preparation of the traxcess for the second pass, small strings were visible at the flexible tip of the wire.Prior to the third pass more strings were observed at the tip.It was reported that a metal introducer was used for advancing the traxcess into the hub of the microcatheter.The traxcess was exchanged to another traxcess wire and the examination was finished.No harm or injury was reported.
Additional Manufacturer Narrative
The visual inspection of the returned device found unknown material along multiple sections of the device.Based on the investigation results, the following causes can be considered for this issue: - black foreign material/ white foreign material these foreign materials were thought to be natural cellulose fibers such as medical gauze.Therefore, when medical gauze or the like comes into contact with the actual sample, it is highly likely that the foreign materials adhered to the actual sample.- blue foreign material based on the condition of the actual sample and the results of the simulation test, it is possible that the actual sample was withdrawn while the surface of its shaft section was in contact with a hard object such as the edge of metal inserter, which resulted in the peeling of outer layer.

• 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: 14973899
• Report Number: 2032493-2022-00260
• Device Sequence Number: 17402225
• Product Code: MOF
• UDI-Device Identifier: 00810170012280
• UDI-Public: (01)00810170012280(11)211102(17)241031(10)211102
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/27/2022

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: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: GW1420040
• Device Catalogue Number: GW1420040
• Device Lot Number: 211102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 07/10/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2021
• 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: 58 YR
• Patient Sex: Male