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

Model Number	29462
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the severely tortuous vessel in the liver.A renegade hi-flo fathom system was selected for use.During advancement of the device to the lesion, resistance occurred.It was noted that the tip of the fathom guidewire broke following removal of the system.The procedure was completed with another of the same device.There were no patient complications, and the patient was stable post procedure.
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the severely tortuous vessel in the liver.A renegade hi-flo fathom system was selected for use.During advancement of the device to the lesion, resistance occurred.It was noted that the tip of the fathom guidewire broke following removal of the system.The procedure was completed with another of the same device.There were no patient complications, and the patient was stable post procedure.It was further reported that the physician was able to recapture all the pieces of the device from the patient.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.B5: describe event or problem: additional information.Device evaluated by mfr: the returned product consisted of a renegade hi flo micro-catheter and a fathom guidewire.Upon visual inspection, it was observed that the renegade device was kinked 128.2 cm from the hub.The fathom guidewire showed a break located 167.7cm from the proximal end of the wire.The returned portion was 167.7cm long; however, approximately 10cm of the guidewire was not returned.A kink on the guidewire was also confirmed located 117cm from the proximal end.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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16294790
• Report Number: 2124215-2023-03609
• Device Sequence Number: 14960745
• Product Code: KRA
• UDI-Device Identifier: 08714729790877
• UDI-Public: 08714729790877
• Combination Product (Y/N): N
• PMA/510(K) Number: K140329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2023

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: 03/15/2025
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0029053994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female