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

Model Number	29460
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2018.It was reported that the tip of the microcatheter was lifted up.A 135/20 renegade hi-flo kit was selected for use.During the procedure, it was reported that the tip of the microcatheter was lifted up and the device could not cross the lesion.The procedure was completed with another of the same device.There were no patient complications reported.The patient condition was stable.However, device analysis revealed shaft fracture and perforation.Device eval by manufacturer: returned product consisted of a renegade hi-flo micro-catheter with a guidewire stuck in the device.The hub, shaft and tip were microscopically examined.The shaft showed multiple kinks throughout its length.The shaft was fractured in 2 places.The 1st fracture was located 11.5cm from the hub and the 2nd fracture was located 25cm from the hub.The device showed that the guide wire had perforated the shaft.The location of the perforation was 18cmcm from the tip.The device was stretched from the tip to 18cm proximally.The wire could not be removed due to the damage of the shaft constricting down on the guidewire.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: 7938910
• Report Number: 2134265-2018-61629
• Device Sequence Number: 2254913
• 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
• Report Date (Section B): 10/05/2018

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: 09/12/2019
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0021250279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1