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

Model Number	80619
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.
Event or Problem Description
It was reported that microcatheter fracture occurred.A single/027/straight/1ro/155 direxion hi-flo was selected for liver cancer treatment.During the procedure, it was found that the microcatheter was fractured.The device was replaced for another of the same model to complete the procedure.No complications reported, and patient status was stable.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.B5 - describe event or problem: added information, based on additional information.Device evaluated by mfr: the device was returned for evaluation.Visual and microscope inspection were performed.Inspection of the device revealed a nickel shaft fracture located at 2 cm from the strain relief.Inspection of the returned device revealed a nickel shaft fracture.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that microcatheter fracture occurred.A single/027/straight/1ro/155 direxion hi-flo was selected for liver cancer treatment.During the procedure, it was found that the microcatheter was fractured.The device was replaced for another of the same model to complete the procedure.No complications reported, and patient status was stable.It was further reported that the fracture was about 5 to 10cm from the hub.

• Brand Name: DIREXION HI-FLO
• 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: 20495026
• Report Number: 2124215-2024-64663
• Device Sequence Number: 4106350
• Product Code: KRA
• UDI-Device Identifier: 08714729839491
• UDI-Public: 08714729839491
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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: 01/19/2025
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0030889804
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 10/27/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2023
• 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