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

Model Number	84591
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip dislodgement occurred.A direxion hi-flo fathom-16 system was selected for use.During preparation, it was noted that the tip of the catheter dislodged when the mandrel was taken out; catheter was then disposed.No patient complications were reported.

• 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: 7965760
• Report Number: 2134265-2018-61880
• Device Sequence Number: 1747105
• Product Code: KRA
• UDI-Device Identifier: 08714729839712
• UDI-Public: 08714729839712
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Type of Report: Initial
• 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: 08/08/2020
• Device Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0022490973
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/15/2018
• Patient Sequence Number: 1