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	04/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter broke.A 130 cm direxion hi-flo fathom-16 system was selected for use.During procedure, it was noted that the microcatheter split at the hub and about half way along.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device showed damage in the form of 4 fractures.The fractures were located at the hub, 3.5cm from the hub, 21.5cm from the hub and 53cm from the hub.The device was not completely separated the inner liner was still attached.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
It was reported that the catheter broke.A 130cm direxion hi-flo fathom-16 system was selected for use.During procedure, it was noted that the microcatheter split at the hub and about half way along.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the catheter was discovered to be broken while outside the patient.

• 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: 8616385
• Report Number: 2134265-2019-05334
• Device Sequence Number: 19406526
• Product Code: KRA
• UDI-Device Identifier: 08714729839682
• UDI-Public: 08714729839682
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/19/2019

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: 10/03/2020
• Device Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0022747596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2019
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1