MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUSELECT?; CATHETER, CONTINUOUS FLUSH

Model Number	M001394111550
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the devices were entrapped.A truselect microcatheter and a fathom 14 guidewire were selected for use.During the procedure, the guidewire would not track through the microcatheter easily, and there was difficulty removing the guidewire from the microcatheter.Both devices had to be removed together from the patient.The procedure was completed with a new truselect and a new fathom.There were no patient complications as a result of this event.

• Brand Name: TRUSELECT?
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22579796
• Report Number: 2124215-2025-49577
• Device Sequence Number: 15461050
• Product Code: KRA
• UDI-Device Identifier: 08714729976660
• UDI-Public: (01)08714729976660(17)261210(10)35464633
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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 Model Number: M001394111550
• Device Catalogue Number: M001394111550
• Device Lot Number: 0035464633
• 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: 06/26/2025
• Initial Report FDA Received Date: 07/23/2025
• Date Device Manufactured: 12/10/2024
• 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 Sex: Unknown