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

Model Number	29420
Medical Device Problem Codes	Stretched (1601); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11232592
• Report Number: 2134265-2021-00719
• Device Sequence Number: 3718337
• Product Code: KRA
• UDI-Device Identifier: 08714729280606
• UDI-Public: 08714729280606
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1