MAUDE Adverse Event Report: EV3, INC. TRAILBLAZER SUPPORT CATHETER; CATHETER, PERCUTANEOUS

Model Number	SC-014-135
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
While using a trailblazer catheter from ev3, approximately a 3-inch segment of the tip broke off while the surgeons were trying to insert it into the sheath.The surgeons were able to retrieve the entire catheter.Fda safety report id # (b)(4).

• Brand Name: TRAILBLAZER SUPPORT CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): EV3, INC.; plymouth MN 55442
• MDR Report Key: 15605917
• Report Number: MW5112623
• Device Sequence Number: 6240913
• Product Code: DQY
• UDI-Device Identifier: 00763000104740
• UDI-Public: (01)00763000104740
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/11/2022

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: 01/18/2025
• Device Model Number: SC-014-135
• Device Lot Number: B325097
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/13/2022
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic