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

Model Number	80619
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microcatheter detachment occurred.A direxion hi-flo was selected for use in a transarterial chemoembolisation (tace) procedure.During the procedure, it was noted that the microcatheter became stuck and resistance felt when the catheter was removed.The device was removed together with the non-boston scientific (bsc) imaging catheter, and it was noted that it got separated.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that the microcatheter detachment occurred.A direxion hi-flo was selected for use in a transarterial chemoembolisation (tace) procedure.During the procedure, it was noted that the microcatheter became stuck and resistance felt when the catheter was removed.The device was removed together with the non-boston scientific (bsc) imaging catheter, and it was noted that it got separated.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The device was examined visually, and it was found that there were fractures in the nitinol shaft, approximately 46.5cm from the microcatheter hub and 12cm from the microcatheter tip.The device was also separated at 24cm from the microcatheter tip.No other issues were identified during the product analysis.

• 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: 19004655
• Report Number: 2124215-2024-16235
• Device Sequence Number: 8434639
• Product Code: KRA
• UDI-Device Identifier: 08714729839545
• UDI-Public: 08714729839545
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/06/2024

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: 09/03/2025
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0032350839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2023
• 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