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

Model Number 29462

Device Problems Material Integrity Problem (2978); Separation Problem (4043)

Patient Problem No Patient Involvement (2645)

Event Date 07/13/2019

Event Type  malfunction  

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 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
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8903888
• MDR Text Key: 154717081
• Report Number: 2134265-2019-09845
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729790860
• UDI-Public: 08714729790860
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K140329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1