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

Model Number	84591
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microcatheter fractured.An 0.027in bern 130cm direxion hi-flo fathom-16 system was selected for use in a transarterial chemoembolization (tace) procedure.The patient was being treated for liver cancer.The target vessel was mildly tortuous.During use of the direxion microcatheter together with the fathom guidewire, the direxion broke completely at approximately 20cm from the hub.All parts were able to be pulled from the patient, and the direxion was replaced with a renegade microcatheter to successfully complete the procedure.No patient complications were reported.
Event or Problem Description
It was reported that the microcatheter fractured.An 0.027in bern 130cm direxion hi-flo fathom-16 system was selected for use in a transarterial chemoembolization (tace) procedure.The patient was being treated for liver cancer.The target vessel was mildly tortuous.During use of the direxion microcatheter together with the fathom guidewire, the direxion broke completely at approximately 20cm from the hub.All parts were able to be pulled from the patient, and the direxion was replaced with a renegade microcatheter to successfully complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: the direxion microcatheter was returned to boston scientific for analysis.The device shaft was visually and microscopically analyzed for any damage.The device showed 2 fractures located 90.7cm and 97.5cm from the hub.The device was not completely separated; the inner liner was still attached.The device showed fractures only.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.A fractured shaft was confirmed.

• 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: 18551938
• Report Number: 2124215-2024-02708
• Device Sequence Number: 6411787
• 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,Followup
• Report Date (Section B): 03/13/2024

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: 05/24/2025
• Device Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0031696526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• 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