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

Model Number	84592
Medical Device Problem Codes	Entrapment of Device (1212); Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the liver.A direxion fathom-16 system was selected for use.During procedure, the microcatheter was in patient and attached to the victoria syringe from the vectorio system.The syringe had lipiodol, doxorubiun and visipaque in it to administer to patient.The lipiodol/doxorubiun combination was given at approximately 1500 and was being slowly pushed for approximately 10 minutes.After it was administered, it was noted that the outer rim at the hub of the microcatheter could not be removed as it had melted.The physician was unable to give particles due to malfunction microcatheter and had to be removed.The procedure was cancelled as a result.No patient complications were reported.

• Brand Name: DIREXION FATHOM-16 SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11894050
• Report Number: 2134265-2021-06154
• Device Sequence Number: 3685950
• Product Code: KRA
• UDI-Device Identifier: 08714729839637
• UDI-Public: 08714729839637
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2021

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 Expiration Date: 01/05/2023
• Device Model Number: 84592
• Device Catalogue Number: 84592
• Device Lot Number: 0026582625
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1