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

Model Number	29460
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter break occurred.A 135/20 renegade hi-flo kit was selected for use.During the procedure, it was noted that the catheter was broken and twisted.The procedure was completed with another of the same device.No patient complications were reported and the patient's status post-procedure was stable.
Event or Problem Description
It was reported that a catheter break occurred.A 135/20 renegade hi-flo kit was selected for use.During the procedure, it was noted that the catheter was broken and twisted.The procedure was completed with another of the same device.No patient complications were reported and the patient's status post-procedure was stable.Device evaluated by mfr: the device was returned for analysis.Returned product consisted of a renegade hi-flo micro-catheter.The hub, shaft and tip were microscopically examined.The device showed buckling from the hub to 9cm distally.The device showed multiple kinks throughout the catheter shaft.The extreme damage that was noticed on this device is consistent with handling and may have had interference with another device.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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: 7901636
• Report Number: 2134265-2018-61230
• Device Sequence Number: 13508352
• 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): 10/18/2018

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: 01/31/2019
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0020353266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Initial Date Received by Manufacturer: 09/03/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1