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

Model Number	M001394101300
Medical Device Problem Codes	Nonstandard Device (1420); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device became crushed.The 130 cm truselect catheter was used for a prostate artery embolization.During the procedure, the catheter was inserted and particle delivery went smoothly; there were no issues with tracking, guidewire, or particle delivery.When the truselect catheter was removed to gain access to the other side, resistance was encountered when removing the catheter.Then it was noted that the catheter was visibly collapsed/squished/crushed toward the distal end.The guidewire could not be fed through but was backloaded successfully, allowing delivery to the other side with this catheter.There were no patient complications.
Event or Problem Description
It was reported that the device became crushed.The 130cm truselect? catheter was used for a prostate artery embolization.During the procedure, the catheter was inserted and particle delivery went smoothly; there were no issues with tracking, guidewire, or particle delivery.When the truselect catheter was removed to gain access to the other side, resistance was encountered when removing the catheter.Then it was noted that the catheter was visibly collapsed/squished/crushed toward the distal end.The guidewire could not be fed through but was backloaded successfully, allowing delivery to the other side with this catheter.There were no patient complications.
Additional Manufacturer Narrative
Device analysis findings: upon receipt at our post market quality assurance laboratory, this truselect microcatheter was examined.Visual examination revealed a flat shaft section extending from the distal tip to approximately 19cm.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.Risk review: a review of the truselect device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.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.

• 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: 24640441
• Report Number: 2124215-2026-15219
• Device Sequence Number: 9895068
• Product Code: KRA
• UDI-Device Identifier: 08714729976615
• UDI-Public: (01)08714729976615(17)270922(10)37516598
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 04/06/2026

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: M001394101300
• Device Catalogue Number: M001394101300
• Device Lot Number: 0037516598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2025
• 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