MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION? HI-FLO? FATHOM?-16 SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number	M001195740
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event: date of event was approximated to 04/01/2026 as the exact event date was not reported.G4 - premarket / 510(k): k142259, k163701.Investigation results: device technical analysis.Upon receipt at our post market quality assurance laboratory, visual examination revealed a nickel shaft fracture located approximately 48cm and 54cm from the strain relief.A stretched inner shaft is associated with the nickel shaft fracture located approximately 54cm extending to approximately 67.5cm from the strain relief.Microscopic examination revealed the tip of the direxion polymer tip is damaged located at the nickel shaft transition.X-ray imaging confirmed the nickel shaft fracture near the strain relief of the guide catheter.Functional test failed due to the microcatheter is stuck in the guide catheter.No other issues were identified during the product analysis.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 that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a review of the direxion hi-flo 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.
Event or Problem Description
It was reported that removal difficulty occurred.A direxion hi-flo fathom-16 system was selected for use.During the procedure, the direxion pushed through base catheter, however, became stuck when trying to retract back into the base catheter.The direxion seems to be getting caught where the nitinol hypotube and yellow distal tip are glued together.Direxion will pull back into base catheter smoothly until that point makes contact with the distal tip of the base catheter.Seems as if the junction between hypotube and distal tip is too big to pull back into the base catheter then gets stuck.Once stuck, the direxion cannot be advanced forward either.The microcatheter and base catheter were removed as one because the microcatheter was stuck and could not be retracted separately.There were no patient complications as a result of this event.

• Brand Name: DIREXION? HI-FLO? FATHOM?-16 SYSTEM
• 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: 25153679
• Report Number: 2124215-2026-25681
• Device Sequence Number: 9397258
• Product Code: KRA
• UDI-Device Identifier: 08714729839712
• UDI-Public: (01)08714729839712(17)280213(10)38593059
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K142259
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: M001195740
• Device Catalogue Number: M001195740
• Device Lot Number: 0038593059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/12/2026
• Date Device Manufactured: 02/13/2026
• 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 Sex: Unknown