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

Model Number	29420
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device separation occurred.A 135/20 renegade hi-flo was selected for a uterine fibroid embolization (ufe) procedure.During preparation, the device got separated when trying to remove it from the hoop.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that a device separation occurred.A 135/20 renegade hi-flo was selected for a uterine fibroid embolization (ufe) procedure.During preparation, the device got separated when trying to remove it from the hoop.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a renegade hi-flo micro-catheter in the hoop.The device was easily removed from the hoop.Analysis of the tip, and inner/outer shaft included a microscopic and visual inspection.Inspection revealed the outer shaft was separated 74mm from the strain relief with the inner shaft stretched between the separation.Inspection of the remainder of the device, apart from the damage observed revealed no other damage or irregularities.

• Brand Name: RENEGADE HI-FLO
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9335000
• Report Number: 2134265-2019-13904
• Device Sequence Number: 1735101
• Product Code: KRA
• UDI-Device Identifier: 08714729280644
• UDI-Public: 08714729280644
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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: 02/16/2022
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0023510266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1