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

Model Number	29462
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260); Leak/Splash (1354); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was admitted to the hospital beyond standard of care.The target lesion was located in the severely tortuous hepatic artery (liver).A renegade hi-flo fathom system was selected for use.During the procedure, it was noted that since the beginning, the physician could not cannulate several arteries with this microcatheter.The physician detected that the catheter was experiencing some difficulty in advancing and retracting.When it was removed, the catheter was fractured.The microcatheter was pulled from the patient's body and the procedure was completed with another renegade kit.The patient was admitted to the hospital beyond standard of care.No further patient complications were reported.
Event or Problem Description
It was reported that the patient was admitted to the hospital beyond standard of care.The target lesion was located in the severely tortuous hepatic artery (liver).A renegade hi-flo fathom system was selected for use.During the procedure, it was noted that since the beginning, the physician could not cannulate several arteries with this microcatheter.The physician detected that the catheter was experiencing some difficulty in advancing and retracting.When it was removed, the catheter was fractured.The microcatheter was pulled from the patient's body and the procedure was completed with another renegade kit.The patient was admitted to the hospital beyond standard of care.No further patient complications were reported.It was further reported that the patient was admitted to the hospital due to the hepatic chemoembolization procedure he is undergoing as part of his routine cancer treatment.The patient was admitted the same day before the procedure and due to the failure of the procedure (the doctor could not access the area of the tumor he wanted to embolize), it was necessary for him to spend the night in the hospital.It was detected that the renegade microcatheter was broken outside the patient.However, once this was noticed, the microcatheter did not re-enter the patient, so no segment of the broken product was involved with the patient.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Returned product to boston scientific consisted of a renegade hi-flo micro-catheter.The device was inspected for any damage or irregularities.The fathom guidewire was stuck in the device.The renegade showed damage in the form of a fracture located 27cm from the hub.There was a constriction of the guidewire caused by the device fracture.There was also shaft damage located 107cm and 144.5cm from the hub.Evidence shows that the device was used in the body as blood was present on the device and the lumen was occluded with blood.No other damage was noticed.Inspection of the remainder of the device apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
It was reported that the patient was admitted to the hospital beyond standard of care.The target lesion was located in the severely tortuous hepatic artery (liver).A renegade hi-flo fathom system was selected for use.During the procedure, it was noted that since the beginning, the physician could not cannulate several arteries with this microcatheter.The physician detected that the catheter was experiencing some difficulty in advancing and retracting.When it was removed, the catheter was fractured.The microcatheter was pulled from the patient's body and the procedure was completed with another renegade kit.The patient was admitted to the hospital beyond standard of care.No further patient complications were reported.It was further reported that the patient was admitted to the hospital due to the hepatic chemoembolization procedure he is undergoing as part of his routine cancer treatment.The patient was admitted the same day before the procedure and due to the failure of the procedure (the doctor could not access the area of the tumor he wanted to embolize), it was necessary for him to spend the night in the hospital.It was detected that the renegade microcatheter was broken outside the patient.However, once this was noticed, the microcatheter did not re-enter the patient, so no segment of the broken product was involved with the patient.

• 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: 12025336
• Report Number: 2134265-2021-07835
• Device Sequence Number: 4269799
• Product Code: KRA
• UDI-Device Identifier: 08714729790884
• UDI-Public: 08714729790884
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/03/2022
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0024057428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Received by Manufacturer: 06/12/2021
• Supplement Date Received by Manufacturer: 06/22/2021; 07/22/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 06/29/2021; 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 77 YR