MAUDE Adverse Event Report: TELEFLEX INCORPORATED TURNPIKE; CATHETER, PERCUTANEOUS

Model Number	IPN917513
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient placed on table and procdure started soon after.Bmw wire inserted then turnpike was inserted.Turnpike was removed soon after.Tip on turnpike was retained in vessel; noted on fluoroscopy.

• Brand Name: TURNPIKE
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 18967783
• Report Number: 18967783
• Device Sequence Number: 6213141
• Product Code: DQY
• UDI-Device Identifier: 10841156108731
• UDI-Public: (01)10841156108731
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2024
• Report Date (Section F): 01/03/2024

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 Model Number: IPN917513
• Device Catalogue Number: 5638
• Device Lot Number: 73M2200340
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 108 KG
• Date Report Sent to FDA: 01/03/2024