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Model Number 29420 |
Device Problem
Difficult to Advance (2920)
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Patient Problem
Vasoconstriction (2126)
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Event Date 07/10/2023 |
Event Type
Injury
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Event Description
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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.
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Manufacturer Narrative
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F10.Removed inadequate/inappropriate treatment or diagnostic exposure code.
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Event Description
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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.
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Search Alerts/Recalls
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