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	11/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter frayed.A direxion hi-flo fathom-16 system was selected for use.During the procedure, when the psi was pushed to 1100, it was noted that the end of the catheter frayed.The device was then simply removed from the sheath.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a direxion hi flo microcatheter.The device was bloody.Analysis of the tip, inner/outer shaft, and hub/strain relief was microscopically and visually inspected.Inspection found no damage or defects with the returned device.
Event or Problem Description
It was reported that the catheter frayed.A direxion hi-flo fathom-16 system was selected for use.During the procedure, when the psi was pushed to 1100, it was noted that the end of the catheter frayed.The device was then simply removed from the sheath.The procedure was completed with another of the same device.There were 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: 9353687
• Report Number: 2134265-2019-14233
• Device Sequence Number: 11363404
• Product Code: KRA
• UDI-Device Identifier: 08714729839682
• UDI-Public: 08714729839682
• 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): 12/17/2019

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 Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0023984401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1