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	06/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record and product release decision control sheet of the involved product/lot# combination were reviewed and no anomaly related to the event was found.The device has not been 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 issue a supplemental mdr report.
Event or Problem Description
It was reported that during a procedure, the physician noted fragments of polytetrafluoroethylene and silicone oil, allegedly stemming from the traxcess microguidewire coating.There was no report of harm or injury to the patient.
Additional Manufacturer Narrative
Summary device evaluation: the investigation of the returned traces device found abrasions at multiple locations along the length.Based on the investigation result, as a possible cause of occurrence, it was likely that the operation of removing the device was performed while the hard object such as the distal end of attached metal inserter was in contact with the surface of the shaft.As a result, each involved section was abraded and the outer layer was peeled off.

• 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: 12448017
• Report Number: 2032493-2021-00367
• Device Sequence Number: 14703158
• Product Code: MOF
• UDI-Device Identifier: 00810170012280
• UDI-Public: (01)00810170012280(11)210316(17)240229(10)210316
• 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: Literature,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: GW1420040
• Device Catalogue Number: GW1420040
• Device Lot Number: 210316
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 47 YR
• Patient Sex: Male