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Lot Number CL12088 |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/04/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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It was reported that during preparation for a procedure a faradrive sheath was selected for use, however, it was found that there was a bubble formation during initial flushing with the syringe.It was not possible to get rid of the bubbles, therefore it was decided to replace the device and the issue was resolved.The procedure was successfully completed with no patient complications.The sheath is expected to be returned for laboratory analysis.
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Search Alerts/Recalls
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