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

Model Number	84592
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter shaft fractured.A direxion infusion catheter was selected for use for a transcatheter arterial chemoembolization procedure in the liver.During the procedure while inside the patient, the nitinol hypotube shaft on the catheter fractured.The procedure was completed with the same device.There were no patient complications reported.
Event or Problem Description
It was reported that the catheter shaft fractured.A direxion infusion catheter was selected for use for a transcatheter arterial chemoembolization procedure in the liver.During the procedure while inside the patient, the nitinol hypotube shaft on the catheter fractured.The procedure was completed with the same device.There were no patient complications reported.Device evaluated by mfr: the shaft was microscopically examined.The device showed damage in the form of a separation located at 41.3cm from the hub.The device was not completely separated the inner liner was still attached.The fractured ends look to be consistent with a tensile fracture.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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: 7906927
• Report Number: 2134265-2018-61078
• Device Sequence Number: 1683111
• Product Code: KRA
• UDI-Device Identifier: 08714729839637
• UDI-Public: 08714729839637
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2018

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: 01/12/2020
• Device Model Number: 84592
• Device Catalogue Number: 84592
• Device Lot Number: 0021603136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1