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

Model Number 29462

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2018

Event Type  malfunction  

Event Description

It was reported that the there was difficulty removing the device.A 115cm 20 renegade hi-flo fathom system was selected for use.During procedure, there was difficulty pushing the microcatheter through celiac trunk.After arriving at the hepatic artery, it was not able to be pushed forward anymore in the non-tortuous vessel.The device was then removed with a little bit of difficulty.The procedure was completed with a different device.No patient complications were reported.Patient condition was stable.

Event Description

It was reported that the there was difficulty removing the device.A 115cm 20 renegade hi-flo fathom system was selected for use.During procedure, there was difficulty pushing the microcatheter through celiac trunk.After arriving at the hepatic artery, it was not able to be pushed forward anymore in the non-tortuous vessel.It was further noted that the guidewire showed a broken tip.The device was then removed with a little bit of difficulty.The procedure was completed with a different device.No patient complications were reported.Patient condition was stable.Device evaluated by mfr.: the device was returned for evaluation.A microscopic examination noted that a guidewire would not exit the catheter shaft.The guidewire showed a broken tip.The tip was not completely separated the inner coil was still connected.The catheter showed damage in the form of 1 kink located 10.5cm from the hub.The catheter and the guidewire that was in the device were soaked in a 37c bath for a period of 48hrs.The guidewire was then removed.The guidewire sticking may have been related to the procedural factors such as contrast or blood.The kink may have also caused the guidewire sticking issue which was located 1.5cm from the distal end of the guidewire.The guidewire was then redelivered into the catheter and the catheter was inserted into a 5fr guide catheter.The device passed through the guide catheter with no hesitations or restrictions.The inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.

• 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
• MDR Report Key: 7918783
• MDR Text Key: 122046628
• Report Number: 2134265-2018-61401
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K140329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

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
• Device Operator: Health Professional
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 09/28/2018
• Supplement Dates Manufacturer Received: 10/03/2018
• Supplement Dates FDA Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1