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

Model Number	29420
Medical Device Problem Codes	Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the microcatheter broke which leads to patient's drug doses falling short of medical prescriptions.A 135/20 renegade hi-flo catheter-infusion was used in the continuous transcatheter hepatic artery drug delivery for hepatocellular carcinoma.During usage, it was noted that the microcatheter was damaged and leaking resulting in patient's drug doses falling short of medical prescriptions.The specific lost drug dose could not be assessed.The microcatheter was removed and a spare large catheter was used to administer the drug.There were no obvious signs of harm and the patient was under further observation.
Event or Problem Description
It was reported that the microcatheter broke which leads to patient's drug doses falling short of medical prescriptions.A 135/20 renegade hi-flo catheter-infusion was used in the continuous transcatheter hepatic artery drug delivery for hepatocellular carcinoma.During usage, it was noted that the microcatheter was damaged and leaking resulting in patient's drug doses falling short of medical prescriptions.The specific lost drug dose could not be assessed.The microcatheter was removed and a spare large catheter was used to administer the drug.There were no obvious signs of harm and the patient was under further observation.It was further reported that the the catheter was 20cm in when the leak was noted outside the patient about 10cm.After procedure during ward round, the physician decided to draw the device from patient.

• Brand Name: RENEGADE HI-FLO
• 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: 15108664
• Report Number: 2124215-2022-24513
• Device Sequence Number: 17191152
• Product Code: KRA
• UDI-Device Identifier: 08714729280644
• UDI-Public: 08714729280644
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/30/2022

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: 05/18/2024
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0027517066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male