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

Model Number	84591
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter broke in half.A direxion hi-flo fathom-16 system was selected for use.During the procedure, it was noted that the catheter came apart and broke in half.The procedure was completed with another of the same device.No patient complications were reported and patient was fine post procedure.
Event or Problem Description
It was reported that the catheter broke in half.A direxion hi-flo fathom-16 system was selected for use.During the procedure, it was noted that the catheter came apart and broke in half.The procedure was completed with another of the same device.No patient complications were reported and patient was fine post procedure.It was further reported that the target lesion was located in the mildly tortuous and moderately calcified lower leg.The device was pulled out and was completely removed from the patient's body.The catheter was no longer intact during removal.The patient was doing well 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: 9841732
• Report Number: 2134265-2020-03332
• Device Sequence Number: 19547040
• Product Code: KRA
• UDI-Device Identifier: 08714729839712
• UDI-Public: 08714729839712
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

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: 12/08/2021
• Device Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0024897592
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1