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

Model Number	29460
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device broke.A 130/20 renegade hi-flo kit was selected for use.During preparation, flushing was done in the hoop and the catheter.However, when the catheter and the wire was removed from the hoop, the catheter was fractured and exposed some of the braiding of the device.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis with a guide wire in the shaft of the catheter.The tip, inner/outer shaft and hub were microscopically and visually inspected.Inspection revealed a complete separation in the outer shaft located 6cm from the strain relief, and the inner shaft was damaged (stretched) approximately 3.5cm.Inspection of the remainder of the device, apart from the damage observed revealed no other damage or irregularities.The guide wire that was in the loaded in the shaft with the returned device was tested for functionality.While the guide wire could be advanced in the inner shaft, the wire could not be withdrawn.The inner shaft damage would not allow the wire to be withdrawn.
Event or Problem Description
It was reported that the device broke.A 130/20 renegade hi-flo kit was selected for use.During preparation, flushing was done in the hoop and the catheter.However, when the catheter and the wire was removed from the hoop, the catheter was fractured and exposed some of the braiding of the device.The procedure was completed with another of the same device.No patient complications were 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: 8799024
• Report Number: 2134265-2019-08345
• Device Sequence Number: 3026921
• Product Code: KRA
• UDI-Device Identifier: 08714729280781
• UDI-Public: 08714729280781
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/21/2019

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: 02/08/2021
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0023465556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1