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

Model Number	29460
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was fractured.The target lesion area was located in the liver.A 135/20 renegade hi flo kit catheter infusion was selected for use in a chemoembolization procedure.During preparation, it was noted that the device was fractured.The procedure was completed with another of the same device.There were no patient complications reported and the patient is stable.
Event or Problem Description
It was reported that the device was fractured.The target lesion area was located in the liver.A 135/20 renegade hi flo kit catheter infusion was selected for use in a chemoembolization procedure.During preparation, it was noted that the device was fractured.The procedure was completed with another of the same device.There were no patient complications reported and the patient is stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was inspected for any damage or irregularities.The renegade showed damage in the form of a stretching and a fracture located 9.5cm from the hub.The device was not completely separated, the inner liner was still attached.The device showed no other damage.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Device analysis determined the condition of the returned device was consistent with the reported information.The shaft fracture was confirmed.

• 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: 10968738
• Report Number: 2134265-2020-17077
• Device Sequence Number: 4168812
• 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): 01/19/2021

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: 05/14/2021
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0023953295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Received by Manufacturer: 11/27/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 62