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Model Number DBP-200SOLID145 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Vascular System (Circulation), Impaired (2572)
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Event Date 03/31/2020 |
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 the reported oad was unable to be reviewed, as the lot number was not provided.If the lot number is provided, a dhr review will be performed.Additional information regarding the current patient status and patient demographics has been requested from the site, but has not been received.If additional information is received a supplemental report will be submitted.Csi id# (b)(4).
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Event Description
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A diamondback peripheral orbital atherectomy device was operated successfully in a heavily calcified, single run off popliteal artery.An angiogram was performed post-procedure and showed good results, with no emboli observed.The patient had strong pulses and was sent to the recovery room.The patient began to experience pain in the lower leg and it was noted that they had livedo reticularis.The patient was treated pharmacologically and as of (b)(6) 2020 the patient's toe was purple, and may have to be amputated.Per the opinion of the physician, a smaller oad should have been used in the vessel, and the csi device is not at fault, due to the high risk and highly calcified vessel of the case.
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Search Alerts/Recalls
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