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

Model Number	29462
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter broke.A renegade hi-flo fathom system was selected for use.The catheter broke when passing the embolization coil.The procedure was completed with a different catheter.No patient complications were reported.
Event or Problem Description
It was reported that the catheter broke.A renegade hi-flo fathom system was selected for use.The catheter broke when passing the embolization coil.The procedure was completed with a different catheter.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned device was inspected for any damage or irregularities.The renegade showed damage in the form of some stretching and a fracture located 2cm from the hub.The device was not completely separated a very small thread of the inner liner was still connected.There was some kinks and shaft damage located approximately 2.5cm to 3.0cm from the tip.Blood was noticed inside the distal part of the devices lumen.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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: 9770278
• Report Number: 2134265-2020-02241
• Device Sequence Number: 778803
• Product Code: KRA
• UDI-Device Identifier: 08714729790877
• UDI-Public: 08714729790877
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2020

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: 05/22/2022
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0023840441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1