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 01/23/2021 |
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 heavily calcified, moderately tortuous, left anterior descending (lad) artery.During the procedure it was noted that the attached copilot rotating hemostatic valve (rhv) was continuously leaking.The copilot was removed and replaced with a new copilot to successfully complete 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.There was no damage noted to the rhv.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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the device was not properly connected resulting in the reported leak.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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