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

Model Number	29462
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated as event date was not reported.Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a renegade hi-flo micro-catheter.The hub, shaft and tip were microscopically examined.This device showed damage consisting of 1 fracture on the shaft located at 34.5cm from the hub.The shaft was not completely separated the inner liner was still connected.The fracture that was noticed on the device are consistent with the device being removed from the shipping tube without being completely hydrated with saline.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 11-jan-2019.It was reported that the device would not come out of the plastic hoop.A renegade hi-flo fathom system was selected for use.During preparation, the device would not come out of the plastic hoop.There were no patient complications reported.However, device analysis revealed one fracture on the shaft located at 34.5cm from the hub.

• Brand Name: RENEGADE HI-FLO FATHOM SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8282246
• Report Number: 2134265-2019-00450
• Device Sequence Number: 1448516
• Product Code: KRA
• UDI-Device Identifier: 08714729790860
• UDI-Public: 08714729790860
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/28/2019

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: 01/11/2021
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0021603099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1