Model Number DBEC-125 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/06/2023 |
Event Type
Injury
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Manufacturer Narrative
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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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A diamondback 360 coronary orbital atherectomy device (oad) was used to treat an unknown lesion in the patient.The patient experienced an acute right middle cerebral artery (mca) stroke.Tissue plasminogen activator (tpa) was administered, and the patient went to interventional radiology (ir) for a thrombectomy procedure.The right mca was near occlusion.A non-csi devices were used to complete the procedure, however, the patient expired.
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Event Description
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Additional information received indicated the adverse event was not related to the orbital atherectomy procedure.
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Manufacturer Narrative
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Additional information received indicated the adverse event was not related to the orbital atherectomy procedure.Therefore, this is no longer a reportable adverse event.
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Manufacturer Narrative
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H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that vascular dissection is a potential adverse event that may occur and/or require intervention with use of the system.The device history record for the reported oad could not be reviewed as the lot number was not provided.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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The clinical event committee reviewed the images and concluded that the use of the diamondback 360 coronary orbital atherectomy device may have contributed to a major dissection.
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Search Alerts/Recalls
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