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

Model Number	84591
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the catheter shaft broke.A 130 direxion hi-flo fathom-16 system was selected for use for transcatheter arterial chemoembolization (tace) procedure in the liver.The target lesion had more than normal tortuosity and some friction was felt during advancement of the direxion.During the procedure inside the patient, the direxion became stuck in a the catheter and the shaft broke.The microcatheter was then pulled out from the patient's body.The procedure was completed with another 130 direxion hi-flo fathom-16 system.There were no patient complications and the patient's status was good post procedure.

• Brand Name: DIREXION HI-FLO 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: 9233670
• Report Number: 2134265-2019-12907
• Device Sequence Number: 411026
• Product Code: KRA
• UDI-Device Identifier: 08714729839712
• UDI-Public: 08714729839712
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Report Date (Section B): 10/24/2019

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: 03/13/2021
• Device Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0023485391
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1