Model Number M00139553CEA0 |
Device Problems
Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993); Radiation Underexposure (3018)
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Patient Problems
Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/20/2020 |
Event Type
malfunction
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Event Description
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It was reported that a procedural related dissection occurred.In (b)(6) 2020, a misadministration of therasphere y-90 microspheres occurred.The physician was unable to inject the therasphere from the delivery apparatus into the patient.Seven days later, a repeat procedure was attempted, however, the injection attempt failed.During this procedure, stenosis in the femoral artery was identified.The patient was given blood thinners.The stenosis is thought to be either the dissection of the arterial wall from the non-bsc closure device, or it was the displaced closure device itself from the first therasphere procedure.In late (b)(6) 2020, the patient reported difficulty in walking, their leg would go numb and essentially feel dead and heavy.The patient sought medical advice.After imaging of the artery was completed, the patient learned that the closure device had collapsed into the artery and the arterial wall suffered a dissection.In (b)(6) 2021, a surgeon who specializes in arterial surgery attempted to repair the dissected arterial wall and remove the collapsed angioseal device, however, the patient still experiences leg numbness.
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Event Description
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It was reported that a procedural related dissection occurred.On (b)(6) 2020 the physician was unable to inject the therasphere y-90 microspheres from the delivery apparatus into the patient.On (b)(6) 2020, a repeat procedure was attempted, however, the injection attempt failed.During this procedure, stenosis in the femoral artery was identified.The patient was given blood thinners.The stenosis was thought to be either the dissection of the arterial wall from the non-boston scientific closure device, or it was the displaced closure device itself from the first therasphere procedure.In late (b)(6) 2020, the patient reported difficulty in walking, their leg would go numb and essentially feel dead and heavy.The patient sought medical advice.After imaging of the artery was completed, the patient learned that the closure device had collapsed into the artery and the arterial wall suffered a dissection.The closure device that was used to close the femoral artery failed, resulting in a dissection in the patient's arterial wall.On (b)(6) 2021, a surgeon who specializes in arterial surgery attempted to repair the dissected arterial wall and remove the collapsed angioseal device, however, the patient still experiences leg numbness.
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Search Alerts/Recalls
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