MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO FATHOM SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number	29462
Medical Device Problem Codes	Material Integrity Problem (2978); Separation Problem (4043)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by the manufacturer: the device was returned for analysis.The tip and inner/outer shaft were microscopically and visually inspected.Inspection revealed the outer shaft was separated at the strain relief, and there was a kink in the shaft located 4mm from the strain relief.
Event or Problem Description
It was reported that the tip of the sheath was disconnected with the tube.A renegade hi-flo fathom system was selected for used.During preparation, when unpacking the plastic package, it was noted that a disconnection from the tube of the tip of the sheath and could not be used.The procedure was completed with another of the same device and the patient is stable.No complications reported.

• Brand Name: RENEGADE HI-FLO FATHOM SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8903888
• Report Number: 2134265-2019-09845
• Device Sequence Number: 16695980
• Product Code: KRA
• UDI-Device Identifier: 08714729790860
• UDI-Public: 08714729790860
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140329
• 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
• Report Date (Section B): 08/16/2019

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: 08/22/2021
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0022555231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1