H6 investigation conclusion code 22: the diamondback 360® peripheral orbital atherectomy system instructions for use manual states that vessel occlusion is a potential adverse event that may occur and/or require intervention with use of the system.H6 results code: 4247 - suggested code is biological material present on device.The oad was returned for analysis.Analysis revealed adhered biological material on the driveshaft at the crown section.Examination did not reveal any damage that would have contributed to the material accumulation.The morphology and exact root cause of the accumulated biological material was unknown.When tested, the oad functioned as intended.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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The diamondback 360 exchangeable peripheral orbital atherectomy device (oad) was used to treat the superficial femoral artery (sfa).The lesion was an in-stent chronic total occlusion (cto).A single vessel runoff to the anterior tibial artery (at) was observed prior to treatment.After treatment, no dissections were observed, however, the at appeared to be occluded.When observing the crown, biological debris was noticed.The at was re-opened with a balloon and tissue plasminogen activator was administered.The procedure was completed with no further issues.
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