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

Model Number	M001195740
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by mfr: the device was received, and analysis was completed.The microcatheter was received as a complete fracture and separation from inner lumen detached from hub adhesive.Microscopic inspection revealed that the nickel shaft was fractured at first perforation at the hub.The inner lumen stretched and kinked.The inner lumen stretched 2cm from proximal end.A broken piece was extracted from the distal tip of shaft that was consistent with a guidewire.X-ray images found broken material in the distal tip.
Event or Problem Description
Reportable based on device analysis completed on (b)(6)2024.It was reported that the hub detached.The patient presented with bleeding from the stomach and had come from the intensive care unit (icu).Profuse bleeding had been observed within the prior 12 hours.A direxion hi-flo fathom-16 system was selected for use to place coils in the left gastric artery.After two unsuccessful attempts to insert coils through the direxion hi-flo catheter hub, the hub detached.No massive bleeding occurred during the procedure.There were no patient complications.However, device analysis revealed a broken guidewire in the distal tip of the catheter shaft.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21058546
• Report Number: 2124215-2024-82818
• Device Sequence Number: 8067722
• Product Code: KRA
• UDI-Device Identifier: 08714729839712
• UDI-Public: 08714729839712
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2025

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: 08/14/2025
• Device Model Number: M001195740
• Device Catalogue Number: M001195740
• Device Lot Number: 0032215434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• 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