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

Model Number	84591
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the outer shaft broke.A direxion hi-flo catheter was selected for use in an embolization procedure.The outer shaft of the catheter broke while inside the patient during the procedure.The device was removed and exchanged for a new device, same model.The procedure was completed.There were no patient complications.
Event or Problem Description
It was reported that the outer shaft broke.A direxion hi-flo catheter was selected for use in an embolization procedure.The outer shaft of the catheter broke while inside the patient during the procedure.The device was removed and exchanged for a new device, same model.The procedure was completed.There were no patient complications.It was further reported that both the inner lumen and nickel shaft were fractured.
Additional Manufacturer Narrative
Device eval by mfr: the device was received and analysis completed.Returned product consisted of a direxion hi flo microcatheter.Inspection of the device revealed a nickel shaft fracture, multiple shaft kinks and stretching.Inspection of the device revealed a nickel shaft fracture and stretching located at the strain relief to 4 cm from the strain relief.Inspection of the returned device revealed a nickel shaft fracture, multiple shaft kinks and stretching.

• 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: 19983624
• Report Number: 2124215-2024-49407
• Device Sequence Number: 11444406
• Product Code: KRA
• UDI-Device Identifier: 08714729839712
• UDI-Public: 08714729839712
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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,Followup
• Report Date (Section B): 09/13/2024

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: 03/01/2025
• Device Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0031153338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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: Male
• Patient Weight: 85 KG