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); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.Returned product consisted of a direxion micro-catheter.The device showed damage in the form of 2 fractures.The fractures were located 3.5cm from the hub and 50cm from the hub.The device was not completely separated the inner liner was still attached.The fracture at the strain relief looks to be consistent with a bending force break.The fracture at the 50cm location is consistent with a tensile break as some of the coils look to be stretched.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 device was fractured.Vascular access was obtained via radial approach.The target lesion was located in right uterine artery.A direxion hi-flo fathom-16 system was selected for use.During procedure, it was found out that the catheter was kinked and fractured in y-adapter; one fracture right at the hub and the other about 15-20cm from the hub.Consequently, it was difficult to inject microspheres so the catheter was removed from the patient's body.Another of the same catheter was used and completed the procedure.No complications were reported and the patient is stable.

• 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: 8433662
• Report Number: 2134265-2019-02697
• Device Sequence Number: 1254173
• Product Code: KRA
• UDI-Device Identifier: 08714729839729
• UDI-Public: 08714729839729
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 03/19/2019

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: 12/06/2020
• Device Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0023047688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR