CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE
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Model Number DBP-200SOLID145 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Embolism/Embolus (4438); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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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.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements prior to distribution.(b)(4).
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Event Description
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A diamondback peripheral orbital atherectomy device (oad) was used to treat a lesion in the superficial femoral artery (sfa), and one pass each was performed at high, medium, and low speed.Following atherectomy treatment, plain old balloon angioplasty and inflation of a drug coated balloon was performed.Runoff images were obtained and the anterior tibial (at) and posterior tibial (pt) arteries were shut down.The pt was revascularized and thrombolysis was performed overnight on the at.The patient was in stable condition following the procedure.Per the opinion of the physician, the cause of the vessel shut down was showering of emboli related to atherectomy treatment in the sfa.
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Search Alerts/Recalls
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