CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE
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Model Number DBP-125SOLID145 |
Device Problem
Entrapment of Device (1212)
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Patient Problems
Pain (1994); Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/15/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.(b)(4).
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Event Description
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A diamondback peripheral orbital atherectomy device (oad) was used for treatment of the distal posterior tibial artery (pt) and proximal pedal arch.Intravenous ultrasound showed calcium proximal to the chronic total occlusion (cto).Atherectomy was performed on the distal segment of the pt.However, the oad stopped spinning when it was advanced to the cto segment.Several attempts to reactivate the device were made, but it would not spin and appeared to be entrapped.The physician administered 1000mcg of nitroglycerin to relieve any spasm.Nitroglycerin did not help to free the oad.Multiple unsuccessful attempts were used to manually remove the oad, but ultimately the patient was sent to surgery for removal in stable condition.The patient experienced pain during removal attempts and received multiple doses of versed and fentanyl.
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