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

Model Number 29420

Device Problems Stretched (1601); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2021

Event Type  malfunction  

Event Description

It was reported that there was a mild resistance when the device was pulled out.A 105/20 renegade hi-flo was selected for use.The non-stenosed target lesion was moderately tortuous and non-calcified.During removal of the device from the patient's body, it was noted that there was a mild resistance when the device was pulled out.Upon checking on the device, it was observed that the tip was stretched and deformed.The procedure was completed with another of same device.No patient complications were reported.

Event Description

It was reported that there was a mild resistance when the device was pulled out.A 105/20 renegade hi-flo was selected for use.The non-stenosed target lesion was moderately tortuous and non-calcified.During removal of the device from the patient's body, it was noted that there was a mild resistance when the device was pulled out.Upon checking on the device, it was observed that the tip was stretched and deformed.The procedure was completed with another of same device.No patient complications were reported.It was further reported that the target lesion was in the hepatic artery.The microcatheter was delivered multiple times.The microcatheter and other devices were sufficiently flushed and hydrated throughout the procedure.The device was removed from the patient's body without any problem.

• Brand Name: RENEGADE HI-FLO
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11232592
• MDR Text Key: 228887940
• Report Number: 2134265-2021-00719
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729280606
• UDI-Public: 08714729280606
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

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 Expiration Date: 07/06/2023
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0025814063
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1