It was reported that the burr was detached and removed with a snare.The 95% stenosed target lesion was located in the mildly tortuous and severely calcified anterior tibial vessel.A 2.00mm peripheral rotalink plus was selected to treat the entire length of the vessel.The burr made a stall sound when approximately 2-3 inches of the vessel was left to treat.Then, the rotapro catheter was removed but it was noted that the burr was sheared off completely and remained behind on the guidewire.Snares were used to remove the device successfully after about 3 hours of extra work.After the detached burr was removed, the vessel was rewired and ballooned to finish the procedure.No patient complications were reported.
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It was reported that the burr was detached and removed with a snare.The 95% stenosed target lesion was located in the mildly tortuous and severely calcified anterior tibial vessel.A 2.00mm peripheral rotalink plus was selected to treat the entire length of the vessel.The burr made a stall sound when approximately 2-3 inches of the vessel was left to treat.Then, the rotapro catheter was removed but it was noted that the burr was sheared off and remained behind on the guidewire.Snares were used to remove the device successfully after about 3 hours of extra work.After the detached burr was removed, the vessel was rewired and ballooned to finish the procedure.No patient complications were reported.
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Device evaluated by mfr.: the device was returned for analysis.The device was received with the burr separated.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found that the coil and burr were detached.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated.When the rotablator advancer was connected to the rotablator console control system and the foot pedal was pressed, the device stalled and would not run.In order to determine the cause for the device stall, destructive testing was performed, in which the advancer was dismantled and the interior components were inspected for damages or defects.During destructive testing, it was identified that the turbine was corroded, indicating the presence of dried saline within the device.It was considered likely that the presence of dried saline interfered with the device's ability to rotate, leading to a device stall.
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