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

Model Number	M001394111550
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis findings: upon receipt at our post market quality assurance laboratory, this truselect microcatheter was examined.Visual examination revealed the shaft was crushed and tangled approximately 7.5cm from the distal tip.The media submitted with the complaint has been thoroughly examined and evaluated to reveal a truselect microcatheter that has a flat shaft and shaft tangled at the distal tip.Device history record (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause linked to device but unable to trace more specifically.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2026.The returned device evaluation revealed the shaft was crushed approximately 7.5cm from the distal tip.A 155cm bern truselect catheter was used for a prostate artery embolization.Accessing a small penile branch to coil took over an hour, but one pushable, and two embold coils were successfully deployed.The microcatheter prolapsed proximally and was removed to regain access into the prostatic artery.Then it was noted that a kink was observed; therefore, the procedure was completed with another of the same device and there were no patient complications.

• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 25009586
• Report Number: 2124215-2026-22704
• Device Sequence Number: 18498581
• Product Code: KRA
• UDI-Device Identifier: 08714729976660
• UDI-Public: (01)08714729976660(17)280113(10)38330781
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/27/2026

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: 0038330781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2026
• 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: 64 YR
• Patient Sex: Male