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

Model Number	29460
Medical Device Problem Codes	Break (1069); Stretched (1601)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter was broken.A 135/20 renegade hi-flo kit was selected for use.Prior preparing the device, it was noted that the catheter was broken and looks like it was stretched when tried to remove from the protective loop.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Analysis of the tip, inner/outer shaft, and hub/strain relief included microscopic and visual inspection.Inspection revealed a fracture in the outer shaft located 1.1cm from the strain relief with outer shaft stretched, and the inner shaft was stretched between the outer shaft fracture faces.Inspection of the rest of the device found no other damage or defect.
Event or Problem Description
It was reported that the catheter was broken.A 135/20 renegade hi-flo kit was selected for use.Prior preparing the device, it was noted that the catheter was broken and looks like it was stretched when tried to remove from the protective loop.The procedure was completed with another of the same device.There were no patient complications reported.

• Brand Name: RENEGADE HI-FLO KIT
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10600739
• Report Number: 2134265-2020-13411
• Device Sequence Number: 2969099
• Product Code: KRA
• UDI-Device Identifier: 08714729280781
• UDI-Public: 08714729280781
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K140329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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: 01/21/2022
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0025242917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1