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); Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty occurred.A direxion hi-flo fathom-16 system was selected for use in a y90 mapping procedure.A radial access approach was used.During procedure, upon advancement of the direxion microcatheter thru the non-bsc diagnostic catheter, the physician noted that resistance was met within the base catheter due to the tortuous anatomy.The direxion fractured at the hub and was difficult to remove.The entire system was removed intact.The procedure was completed with another of the same device.No patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer.Returned product consisted of a direxion hi flo microcatheter with the guide wire in the shaft with a y-connector.The guide wire could not be separated from the catheter.Analysis of the tip, inner/outer shaft, and hub/strain relief included microscopic and visual inspection.Inspection revealed a complete separation of the outer shaft located 34.3 cm from the strain relief with the inner shaft stretched taught in between the separation and over the wire.Inspection of the rest of the device found no other damage or defect.The reported catheter fracture and difficulty removing were confirmed, however, the friction could not be confirmed as clinical circumstances could not be replicated.
Event or Problem Description
It was reported that removal difficulty occurred.A direxion hi-flo fathom-16 system was selected for use in a y90 mapping procedure.A radial access approach was used.During procedure, upon advancement of the direxion microcatheter thru the non-bsc diagnostic catheter, the physician noted that resistance was met within the base catheter due to the tortuous anatomy.The direxion fractured at the hub and was difficult to remove.The entire system was removed intact.The procedure was completed with another of the same device.No patient complications 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: 10138668
• Report Number: 2134265-2020-07774
• Device Sequence Number: 11212718
• 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,Followup
• Report Date (Section B): 07/17/2020

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: 03/18/2022
• Device Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0025373035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/17/2020
• 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