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	07/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microcatheter broke in half.A 130 direxion hi-flo fathom-16 system was selected for use.During the procedure, the coil was inserted into the patient's nose to treat epistaxis.However, the coil would not advance and it was noted that the microcatheter broke into half.The microcatheter was then pulled out from the patient's body.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that the microcatheter broke in half.A 130 direxion hi-flo fathom-16 system was selected for use.During the procedure, the coil was inserted into the patient's nose to treat epistaxis.However, the coil would not advance and it was noted that the microcatheter broke into half.The microcatheter was then pulled out from the patient's body.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by the manufacturer:the device was returned for analysis.Returned product consisted of a direxion microcatheter.Analysis of the tip, shaft and hub/strain relief included microscopic and visual inspection.Inspection revealed a complete separation of the shaft located at the strain relief, the outer shaft separated 10.5cm from the strain relief and 3.5cm from the tip of the device, shaft kink located 77cm from the tip and inner shaft was stretched for 10.5cm starting at the strain relief.Inspection of the rest of the device found no other damage or defect.Fracture/separation of the direxion is attributed to the device not being continuously flushed.The direxion dfu includes the following precaution: "it is recommended that a continuous saline flush be maintained between the microcatheter and the guidewire during the procedure.Flushing prevents contrast crystal formation and/or clotting on the guidewire and in the catheter lumen.".

• 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: 8875286
• Report Number: 2134265-2019-09446
• Device Sequence Number: 2390608
• Product Code: KRA
• UDI-Device Identifier: 08714729839712
• UDI-Public: 08714729839712
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/06/2019

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: 09/13/2020
• Device Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0022653021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1