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 Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device fracture occurred.A renegade hi-flo kit was selected for use.During unpacking of device, the physician found it was fractured.The procedure was completed with a different device.There were no patient complications reported and the patient was stable post procedure.
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 an outer shaft separation located 3.5cm from the strain relief with the inner shaft stretched out between the fracture faces.Inspection of the rest of the device found no other damage or defect.
Event or Problem Description
It was reported that a device fracture occurred.A renegade hi-flo kit was selected for use.During unpacking of device, the physician found it was fractured.The procedure was completed with a different device.There were no patient complications reported and the patient was stable post procedure.

• 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: 10233441
• Report Number: 2134265-2020-08945
• Device Sequence Number: 3373791
• Product Code: KRA
• UDI-Device Identifier: 08714729280781
• UDI-Public: 08714729280781
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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: 05/24/2021
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0023999087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1