Model Number 1003330 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the procedure was to treat a mildly tortuous, mildly calcified right coronary artery.There was a lot of bubbles noted at the tubing that connected to the co-pilot.It was confirmed that there was no connection issue, however it was still decided to change to another new co-pilot which successfully completed the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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The device was returned for analysis.The reported leak was unable to be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.As the reported leak was unable to be confirmed during return analysis, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the device was not fully connected and/or the device seals were not fully tightened/closed thus resulting in the reported leak.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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Search Alerts/Recalls
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