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

Model Number	29460
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: reported as (b)(6).
Event or Problem Description
It was reported that proximal part of the device was separated from its shaft.A 135/20 renegade hi-flo kit was selected for use in the prostate.During preparation for the procedure, after the device was flushed and pulled out smoothly and slowly from inside the sheath, the proximal part was noted to be separated from it's shaft.The device was removed.The procedure was completed with another of the same device.No patient complications reported.
Additional Manufacturer Narrative
A2: age at time of event: reported as 63.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 stretching and a fracture of the shaft.The fracture was located 2.5cm from the hub.The device was not completely separated, the inner liner was still attached.The distal end of the shaft showed multiple kinks and bends located from the tip, proximally to 28cm.
Event or Problem Description
It was reported that proximal part of the device was separated from its shaft.A 135/20 renegade hi-flo kit was selected for use in the prostate.During preparation for the procedure, after the device was flushed and pulled out smoothly and slowly from inside the sheath, the proximal part was noted to be separated from it's shaft.The device was removed.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: 9788020
• Report Number: 2134265-2020-02461
• Device Sequence Number: 2456486
• Product Code: KRA
• UDI-Device Identifier: 08714729280781
• UDI-Public: 08714729280781
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 03/12/2020

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: 01/06/2021
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0023302343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 95