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

Model Number	M001195440
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with history of breast cancer and lever mets (liver metastases?) was admitted for a yttrium-90 radioembolization mapping and therapy.After opening the boston scientific direxion¿ hi-flo¿ torquable microcatheter, it was observed that the silver covering was missing on part of the catheter, with a separation.The faulty torquable microcatheter was not used on the patient.A replacement was used without a problem.

• Brand Name: DIREXION HI-FLO
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12031481
• Report Number: 12031481
• Device Sequence Number: 14343669
• Product Code: KRA
• UDI-Device Identifier: 08714729839514
• UDI-Public: (01)08714729839514(17)220928(10)26089461
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/15/2021
• Report Date (Section F): 06/15/2021

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 Model Number: M001195440
• Device Lot Number: 26089461
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 86
• Date Report Sent to FDA: 06/15/2021