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

Model Number	29462
Medical Device Problem Codes	Break (1069); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter broke.A fathom 16x 180cm renegade hi-flo 135cmx20 was selected for a transcatheter arterial chemoembolization (tace) procedure.During preparation, there was noted to be strong resistance when removing the device from the carrier hoop and the microcatheter broke in the middle.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable post procedure.
Event or Problem Description
It was reported that the catheter broke.A fathom 16x 180cm renegade hi-flo 135cmx20 was selected for a transcatheter arterial chemoembolization (tace) procedure.During preparation, there was noted to be strong resistance when removing the device from the carrier hoop and the microcatheter broke in the middle.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable post procedure.It was further reported that upon removal, the catheter was flushed and then removed from the carrier tube.However, resistance was still felt in removing the device from the packaging.With more time flushing, it became less difficult to remove.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a renegade hi-flo microcatheter in the hoop.The device could not initially be removed from the hoop until the hoop was flushed with fluid.Once hydrated, the device was easily removed.Analysis of the tip, inner/outer shaft, and hub/strain relief included microscopic and visual inspection.Inspection revealed an outer shaft fracture 29.1cm from the strain relief, and the inner shaft was stretched between the outer shaft fracture faces.Inspection of the rest of the device found no other damage or defect.

• 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: 10449360
• Report Number: 2134265-2020-11610
• Device Sequence Number: 19662210
• Product Code: KRA
• UDI-Device Identifier: 08714729790860
• UDI-Public: 08714729790860
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

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: 12/02/2022
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0024862615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1