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

Model Number	29462
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter was in pieces.A 180cm x150cm renegade hi-flo fathom system was selected for use.Upon unpacking, it was noted that the catheter was in pieces; device never went inside patient's body.No patient complications were reported.

• Brand Name: RENEGADE HI-FLO FATHOM SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road,; cork ; EI
• MDR Report Key: 7859931
• Report Number: 2134265-2018-60883
• Device Sequence Number: 1272173
• Product Code: KRA
• UDI-Device Identifier: 08714729790877
• UDI-Public: 08714729790877
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/10/2018

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: 05/09/2021
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0022102186
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/10/2018
• Patient Sequence Number: 1