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

Model Number	29420
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	07/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that vasospasm occurred.The target lesion was in the mildly calcified liver vessel.The blood vessel had two opposite curvatures very close to each other, especially the first one which was nearly 90 degrees.A 135/10 renegade hi flo was selected for use.After a liver procedure, the patient underwent hepatic arteriography and proper hepatic artery chemoembolization due to interventional therapy for malignant tumor and liver malignant tumor.This device was needed for hepatic arterial infusion chemotherapy.The charge nurse took out the microcatheter with complete outer package, and after the physician successfully selected the hepatic artery branch according to the normal operation steps, the operator tried to follow it up with the microcatheter.The microcatheter could not be advanced and failed many times.After the first curvature was crossed, it was difficult to immediately cross the next one at an opposite angle, and the catheter tip was easy to stick against the blood vessel wall.It was found that the patient had vascular spasm which made it impossible to continue the hepatic artery embolization.After use, the blood vessel got wrinkled and spasmodic.The hepatic artery embolization was stopped immediately, and the perfusion chemotherapy was continued.However, the chemotherapy drugs injected into the patient during the infusion chemotherapy were reduced, which might affect the chemotherapy effect.The device was removed through the angiographic catheter and the procedure was completed with a different device.The patient has recovered well and the skin at the puncture site has healed well without redness, swelling and pressing pain.
Additional Manufacturer Narrative
F10.Removed inadequate/inappropriate treatment or diagnostic exposure code.
Event or Problem Description
It was reported that vasospasm occurred.The target lesion was in the mildly calcified liver vessel.The blood vessel had two opposite curvatures very close to each other, especially the first one which was nearly 90 degrees.A 135/10 renegade hi flo was selected for use.After a liver procedure, the patient underwent hepatic arteriography and proper hepatic artery chemoembolization due to interventional therapy for malignant tumor and liver malignant tumor.This device was needed for hepatic arterial infusion chemotherapy.The charge nurse took out the microcatheter with complete outer package, and after the physician successfully selected the hepatic artery branch according to the normal operation steps, the operator tried to follow it up with the microcatheter.The microcatheter could not be advanced and failed many times.After the first curvature was crossed, it was difficult to immediately cross the next one at an opposite angle, and the catheter tip was easy to stick against the blood vessel wall.It was found that the patient had vascular spasm which made it impossible to continue the hepatic artery embolization.After use, the blood vessel got wrinkled and spasmodic.The hepatic artery embolization was stopped immediately, and the perfusion chemotherapy was continued.However, the chemotherapy drugs injected into the patient during the infusion chemotherapy were reduced, which might affect the chemotherapy effect.The device was removed through the angiographic catheter and the procedure was completed with a different device.The patient has recovered well and the skin at the puncture site has healed well without redness, swelling and pressing pain.

• Brand Name: RENEGADE HI-FLO
• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17747123
• Report Number: 2124215-2023-47745
• Device Sequence Number: 14772745
• Product Code: KRA
• UDI-Device Identifier: 08714729280637
• UDI-Public: 08714729280637
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

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: 04/30/2025
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0029505383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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: GUIDE CATHETER: 5F; GUIDE CATHETER: 5F
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Male