Model Number DBP-125SOLID145 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Thrombus (2101); Vascular System (Circulation), Impaired (2572)
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Event Date 06/26/2019 |
Event Type
Injury
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Manufacturer Narrative
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Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.(b)(4).
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Event Description
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A thrombus which resulted in no flow was observed on imaging in the tibioperoneal trunk (tpt) following three treatments on low speed for 20 seconds each with a diamondback peripheral orbital atherectomy device (oad) in the proximal to distal popliteal artery and the posterior tibial artery.A thrombectomy device was used to remove the thrombus and was successful in restoring flow to the tpt.When imaging was performed again, thrombus was observed in the anterior tibial (at) artery, and flow was sluggish.Following treatment of the at with the thrombectomy device, the at was open with moderately brisk flow.Prior to the observation of thrombus following orbital atherectomy, both the tpt and the at were open and flow was normal.The patient had been appropriately heparinized during preparation for the procedure with 6000 units.
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Manufacturer Narrative
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Failure analysis conclusion: the oad was received at csi for analysis and was tested.The oad operated as intended when tested, and fluid was found to flow out the distal end of the saline sheath and driveshaft as expected.There was some adhered biological material on the driveshaft and crown which may have contributed to the reported complaint.However, this is not confirmed.Analysis did not identify any damage that may have contributed to the accumulating material.The morphology and exact root cause of the accumulated biological material is unknown.At the conclusion of the failure analysis investigation the reported thrombus event could not be confirmed through analysis.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.Csi id: (b)(4).
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Search Alerts/Recalls
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