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

Model Number	M001394111300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microcatheter broke.A selective mc single bern 130cm truselect was selected for prostate artery embolization to treat benign prostatic hyperplasia.During removal, it was observed that the catheter broke.The original device was used to successfully complete the procedure prior to the break.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the returned device consists of truselect microcatheter in 2 pieces as the shaft is fractured.Visual examination revealed shaft fractured located approximately 21cm 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: 22816664
• Report Number: 2124215-2025-56460
• Device Sequence Number: 8756735
• Product Code: KRA
• UDI-Device Identifier: 08714729976653
• UDI-Public: (01)08714729976653(17)270604(10)36673335
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/15/2025

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: M001394111300
• Device Catalogue Number: M001394111300
• Device Lot Number: 0036673335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• 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