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

Model Number	80618
Medical Device Problem Codes	Defective Device (2588); Difficult to Open or Remove Packaging Material (2922); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable upon analysis completed 21march2024.It was reported that this microcatheter had kinked.During imaging of a renal embolization procedure using a direxion microcatheter, it was found that the device was faulty during tracking though the anatomy and the hub had kinked.It was noted that the carrier tube was hydrated prior to the removal of the catheter; however, there was a little resistance removing the catheter from the carrier tube.A new device was used to complete the procedure, and no patient complications were reported.However, device analysis revealed a fracture and a device separation.
Additional Manufacturer Narrative
Device eval by manufacturer: this direxion microcatheter was returned and analyzed.Visual inspection of the complaint device revealed a fracture located 3.5 cm, and a separation of the shaft at 24.5 cm from the microcatheter hub.Functional testing was not able to be performed due to the separation.No other visual abnormalities were noted.Analysis of the device found the nitinol shaft was fractured and separated.

• Brand Name: DIREXION
• 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: 19049957
• Report Number: 2124215-2024-20287
• Device Sequence Number: 8482767
• Product Code: KRA
• UDI-Device Identifier: 08714729839453
• UDI-Public: 08714729839453
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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: 05/12/2024
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0029394184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• 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