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

Model Number	29462
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device got fractured.The target lesion was located in the severely tortuous liver.A 180cm renegade hi-flo fathom system-16 was selected for use.During the procedure, a tension was felt, the tip of the wire was sheered and fractured on the distal tip.The wire was retrieved through the catheter and the entire system was pulled out entirely from the patient's body.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
H6 - device code: removed code of "material integrity problem".
Event or Problem Description
It was reported that the device got fractured.The target lesion was located in the severely tortuous liver.A 180cm renegade hi-flo fathom system-16 was selected for use.During the procedure, a tension was felt, the tip of the wire was sheered and fractured on the distal tip.The wire was retrieved through the catheter and the entire system was pulled out entirely from the patient's body.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: RENEGADE HI-FLO FATHOM SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16429464
• Report Number: 2124215-2023-06936
• Device Sequence Number: 2620332
• Product Code: KRA
• UDI-Device Identifier: 08714729790853
• UDI-Public: 08714729790853
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

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: 01/26/2025
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0028756519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER INFUSION - 130CM 2.4F J-SHAPED DIREXION; CATHETER INFUSION - 130CM 2.4F J-SHAPED DIREXION
• Patient Sex: Unknown