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

Model Number	84592
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microcatheter was fractured.Vascular access was obtained via radial access approach.A direxion fathom-16 system was selected for use.During the procedure, when the physician was advancing/manipulating the direxion microcatheter through a non-bsc diagnostic catheter, he met resistance within the base catheter possibly due to the tortuous anatomy.At that point, it was noted that the direxion microcatheter fractured and was removed.The entire system was intact.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The device shaft was analyzed for any damage.The devices shaft showed damage in the form of 1 fracture.The fracture was located 56.7cm from the hub.The device was not completely separated the inner liner was still connected.The fracture looked to be consistent with a bending and tensile force breaking.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 microcatheter was fractured.Vascular access was obtained via radial access approach.A direxion fathom-16 system was selected for use.During the procedure, when the physician was advancing/manipulating the direxion microcatheter through a non-bsc diagnostic catheter, he met resistance within the base catheter possibly due to the tortuous anatomy.At that point, it was noted that the direxion microcatheter fractured and was removed.The entire system was intact.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: DIREXION 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: 10384634
• Report Number: 2134265-2020-10760
• Device Sequence Number: 19299131
• Product Code: KRA
• UDI-Device Identifier: 08714729839637
• UDI-Public: 08714729839637
• 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,Followup
• Report Date (Section B): 08/24/2020

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: 06/29/2022
• Device Model Number: 84592
• Device Catalogue Number: 84592
• Device Lot Number: 0025650767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DIAGNOSTIC CATHETER - TERUMO 5FR SARAH; DIAGNOSTIC CATHETER - TERUMO 5FR SARAH; DIAGNOSTIC CATHETER - TERUMO 5FR SARAH
• Patient Age: 81 YR