A diamondback peripheral orbital atherectomy device (oad) was used to treat a lesion in the tibial artery.During treatment, the oad became stuck on the guide wire and stopped spinning.Glide assist mode was activated in an attempt to disengage the device from the guide wire, however it was unsuccessful, and the oad and guide wire were manually removed by pulling.Tissue was observed to be wrapped around the device, and a resultant vessel perforation was identified.The tibial artery was re-wired and balloon angioplasty was performed.Everything looked good post-angioplasty.
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The oad and guide wire were received at csi for analysis.Visual examination revealed dried biological fluid on the driveshaft and crown.This did not prevent the guide wire from passing through the driveshaft.The morphology and root cause of the accumulation was unknown.The guide wire spring tip proximal coil was stretched but remained intact.Visual analysis did not identify any damage that would have contributed to the reported events.The oad data log was reviewed.The data showed the device had stalled as well as slowed down during the procedure.However, the device functioned as intended during testing.The stalls and decreases in speed observed in the data log could not be duplicated during analysis.It is hypothesized that the oad crown was placed within a tight location of the lesion and did not have sufficient space to begin spinning before treatment, however this could not be confirmed.At the conclusion of the device analysis investigation, the reported perforation and device stuck on wire events could not be confirmed.Although the stalls observed in the data log could not be replicated during analysis, it is possible they may be related to the stuck on wire complaint experienced during the procedure.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.Updated fields: b4, g4, g7, h2, h3, h6, h10.Csi id: (b)(4).
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