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Model Number 3280 |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/19/2022 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was cancelled.A rotalink advancer was selected for use.During preparation, when the physician was connecting the device to nitrogen, the advancer was found leaking.The procedure was cancelled due to this event and the patient was sedated.No complications were reported, and the patient status is stable.
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Event Description
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It was reported that the procedure was cancelled.A rotalink advancer was selected for use.During preparation, when the physician was connecting the device to nitrogen, the advancer was found leaking.The procedure was cancelled due to this event and the patient was sedated.No complications were reported, and the patient status is stable.
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Manufacturer Narrative
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Device evaluated by manufacturer: returned product consisted of the rotablator rotalink plus atherectomy device.The burr catheter was received attached to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually examined.Inspection of the device presented no damage or irregularities.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was not 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.The sound of air escaping the device was heard during the stall.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 examined.Destructive testing was not able to determine the cause of the stall.Product analysis confirmed the reported event, as the sound of air escaping the device could be heard during the device stall.Destructive testing was not able to confirm the cause of the stall.
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Search Alerts/Recalls
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