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

Model Number	M001394111300
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation by manufacturer: the returned device consisted of selective mc single bern 130cm truselect infusion catheter separated into 3 pieces, while one of the pieces was stuck in the non-boston scientific (bsc) catheter.Visual examination revealed shaft separation located approximately 53cm from the strain relief.A segment of the broken shaft was approximately 13.5cm long.The remaining segment was stuck inside the non-bsc catheter.
Event or Problem Description
Reportable based on analysis completed on (b)(6) 2025.It was reported that when the microcatheter entered the bisection, it could not be advanced.The target lesion was located in a mildly tortuous vessel leading to renal hamartoma.A selective mc single bern 130cm truselect infusion catheter was selected to treat the renal hamartoma.When the catheter entered the bisection, however, the catheter became astringent and could not be advanced.After withdrawal, another device was used to complete the procedure.There were no patient complications as a result of this event, and the patient condition following procedure was stable.However, device analysis revealed shaft separation located approximately 53cm from the strain relief.

• 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: 23066195
• Report Number: 2124215-2025-64823
• Device Sequence Number: 13181914
• Product Code: KRA
• UDI-Device Identifier: 08714729976653
• UDI-Public: (01)08714729976653(17)260304(10)33556581
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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 Expiration Date: 03/04/2026
• Device Model Number: M001394111300
• Device Catalogue Number: M001394111300
• Device Lot Number: 0033556581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Weight: 79 KG