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

Model Number	29420
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a renegade hi flo microcatheter in a non-bsc catheter.Analysis of the hub, inner/outer shaft, and tip of the device included microscopic and visual inspection.Inspection revealed 9 cm of the renegade (tip and shaft) was protruding out from the tip of the 4f catheter and had numerous kinks and was damaged (stretched), and the outer shaft was separated 44cm from the strain relief (of the renegade) with the shaft stretched for 21cm (bother inner and outer shafts), with additional kinks on the proximal end of the renegade.Despite soaking, the renegade could not be removed from the other catheter.
Event or Problem Description
Reportable based on device analysis completed on 13sep2019.It was reported that device was stuck in catheter.A 135/20 renegade hi-flo catheter was selected for use.During procedure, resistance was noted and the device got stuck at the 4fr non-bsc contrast catheter lumen.Intermittent flushing was performed.The catheter surface was flushed and the carrier tube was hydrated prior to removal from carrier hoop.The procedure was completed with another of the same renegade and no resistance was felt.No patient complications were reported.However, device analysis revealed the outer shaft was separated 44cm from the strain relief.

• 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: 9152825
• Report Number: 2134265-2019-11903
• Device Sequence Number: 2607348
• Product Code: KRA
• UDI-Device Identifier: 08714729280644
• UDI-Public: 08714729280644
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/03/2019

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: 08/27/2021
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0022715424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1