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	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is an estimated date based off the aware date as the exact event date was not reported.
Event or Problem Description
It was reported that the guidewire covering became separated from the wire.A 180cmx150cmx10 renegade hi-flo fathom system was selected for use.During removal from the protective packaging holder, it was noted that the guidewire covering became separated from the wire.The microcatheter and wire were also stuck in the holder.No patient complications were reported.
Additional Manufacturer Narrative
B3: date of event is an estimated date based off the aware date as the exact event date was not reported.Device evaluated by mfr: the device was returned for evaluation.Analysis of the tip, inner/outer shaft, and hub/strain relief included microscopic and visual inspection.Inspection revealed an outer shaft separation 22mm from the strain relief, shaft buckling 10mm from the strain relief, and the inner shaft was stretched between the fracture faces.Inspection of the rest of the device found no other damage or defect.
Event or Problem Description
It was reported that the guidewire covering became separated from the wire.A 180cmx150cmx10 renegade hi-flo fathom system was selected for use.During removal from the protective packaging holder, it was noted that the guidewire covering became separated from the wire.The microcatheter and wire were also stuck in the holder.No patient complications were reported.

• 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: 10311224
• Report Number: 2134265-2020-09714
• Device Sequence Number: 19679258
• Product Code: KRA
• UDI-Device Identifier: 08714729790877
• UDI-Public: 08714729790877
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

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: 08/07/2022
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0024233847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Initial Date Received by Manufacturer: 07/11/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1