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 Consequences Or Impact To Patient (2199)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by the manufacturer.The device was returned for analysis.Inspection revealed the outer shaft was separated 3mm from the strain relief and the inner stretched for approximately 12mm.Inspection of the remainder of the device, apart from the damage observed revealed no other damage or irregularities.
Event or Problem Description
It was reported that the catheter detach occurred.A 135/20 renegade hi-flo catheter was selected for use.During preparation, it was noted that the catheter was bent in a ring and became unraveled and came apart as it was removed from the carrier hoop.The procedure was completed with another of the same device.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: 8902728
• Report Number: 2134265-2019-09776
• Device Sequence Number: 2128202
• Product Code: KRA
• UDI-Device Identifier: 08714729280781
• UDI-Public: 08714729280781
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 08/16/2019

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: 04/01/2021
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0023731130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1