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	09/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter fracture occurred.The target lesion was located in the adrenal vein.A direxion hi-flo fathom-16 was selected for use.During the procedure upon removal of the device from the patient's body, it was noted that the catheter was fractured approximately 25cm from the distal tip.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that catheter fracture occurred.The target lesion was located in the adrenal vein.A direxion hi-flo fathom-16 was selected for use.During the procedure upon removal of the device from the patient's body, it was noted that the catheter was fractured approximately 25cm from the distal tip.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the device was just removed over the fathom wire at which time the fracture was noticed.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Analysis of the tip, inner/outer shaft and hub/strain relief included microscopic and visual inspection.Inspection revealed the outer shaft fractured 52.5 cm from the strain relief, and the inner shaft was found damaged.Inspection of the rest of the device found no other damage or defect.

• 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: 9119524
• Report Number: 2134265-2019-11612
• Device Sequence Number: 2812027
• 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): 10/23/2019

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: 09/13/2020
• Device Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0022653016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1