Model Number C-2DB-CL125-135 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arrhythmia (1721); Hematoma (1884); Myocardial Infarction (1969); Unspecified Vascular Problem (4441); Heart Block (4444); Unspecified Heart Problem (4454); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/08/2022 |
Event Type
Injury
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Manufacturer Narrative
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Adverse event suggested health effect - clinical code 4581: slow/no flow.The device history record for the reported oad could not be reviewed as the lot number was not provided.If the lot number is provided, a dhr review will be performed.The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Csi id: (b)(4).
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Event Description
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One patient underwent treatment of a lesion in the dominant right coronary artery (rca), and experienced slow flow that led to a hospitalization.The patient discharged in good condition after several days of hospitalization.Two patients experienced atrioventricular block.Two patients experienced temporary conduction disturbances that did not necessitate electrostimulation.Two patients had minor forearm hematomas that did not require surgical intervention.Two patients had vascular complications of percutaneous coronary intervention (pci).One patient had a myocardial infarction.Lastly, one patient had in-hospital major adverse cardiac event (mace).Kralisz et al."use of orbital atherectomy in coronary artery disease with severe calcification: a preliminary study".
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Search Alerts/Recalls
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