CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE
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Model Number DBP-125MICRO145 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Perforation of Vessels (2135)
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Event Date 11/12/2017 |
Event Type
Injury
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Manufacturer Narrative
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The distal driveshaft, saline sheath, and engaged guide wire section were returned for analysis without the oad handle.Examination of the saline sheath and driveshaft sections revealed them to have been destructively cut.The driveshaft filars were found to be stretched and there was adhered biological material on the driveshaft, crown, and exposed guide wire shaft at the tip bushing.Examination in the area of adhered material did not reveal any damage that would have contributed to the accumulation.There was no damage observed with the driveshaft and crown that would have contributed to the reported event.The guide wire exhibited numerous bends along the shaft.Examination of the remaining guide wire shaft did not reveal any additional damage that would have contributed to the reported event.At the conclusion of the device analysis investigation, the root cause of the reported event was unable to be confirmed.(b)(4).
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Event Description
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During a peripheral orbital atherectomy procedure using a csi orbital atherectomy device (oad), it was reported that a perforation occurred.The target lesion was heavily calcified, and was accessed through the groin.The lesion was treated using two passes with the oad, however the device then became stuck in the vessel.A cutdown was performed to remove the device, and the guide wire was noted to be kinked.Imaging was performed and a perforation was noted in the lateral plantar artery.The perforation was resolved without further intervention, and the patient was in stable condition following the procedure.
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