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Model Number 3243 |
Device Problems
Difficult to Flush (1251); Output Problem (3005); Noise, Audible (3273); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/08/2024 |
Event Type
malfunction
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Event Description
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It was reported that the rotation speed was not stable.The target lesion was located in the proximal right coronary artery.A 1.50mm rotapro and rotawire were selected for use.During rotablation, the advancer was stuck in the middle and was unable to move distally.Additionally, there was no drop in speed on the console.An unexpected noise was heard.The set operational speed was 160k to 180k rpm however, the maximum speed reached was190k rpm.The rotapro burr was removed and attempted to be flushed, but was unsuccessful.The procedure was completed successfully using a replacement rotapro, and the same rotawire.There were no patient complications reported.
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Manufacturer Narrative
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Device evaluated by manufacturer: the returned product consisted of the rotapro atherectomy system.Visual inspection of the device did not identify any damages or defects.After destructive testing, it was found that the coil was kinked, stretched, and detached from the handshake connection within the sheath.Wear was identified within the sheath.In functional test, the advancer knob encountered resistance during attempted movement while the advancer and burr housing were connected.The housings were disconnected, and it was found that the handshake connection was within the burr catheter housing and could not be retrieved.After the burr housing was disconnected from the advancer, the advancer knob was able to move back and forth with no resistance or issues.During fluid infusion, there appeared to be a diminished flow of fluid beyond the damaged coil and handshake connection within the sheath.Product analysis confirmed the reported events, as the coil was kinked, stretched, and detached form the handshake connection within the sheath, creating resistance when attempting to adjust the advancer knob, and inhibiting the flow of fluid through the burr catheter.It was considered likely that the reported abnormal noise and high, unstable speeds were attributable to the separated coil, allowing the advancer to rotate at higher speeds without the burr catheter connected.
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Event Description
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It was reported that the rotation speed was not stable.The target lesion was located in the proximal right coronary artery.A 1.50mm rotapro and rotawire were selected for use.During rotablation, the advancer was stuck in the middle and was unable to move distally.Additionally, there was no drop in speed on the console.An unexpected noise was heard.The set operational speed was 160k to 180k rpm however, the maximum speed reached was190k rpm.The rotapro burr was removed and attempted to be flushed, but was unsuccessful.The procedure was completed successfully using a replacement rotapro, and the same rotawire.There were no patient complications reported.
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Search Alerts/Recalls
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