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Model Number ENSITE-SYSTEM-01 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/02/2021 |
Event Type
malfunction
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Event Description
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During a redo parox atrial fibrillation procedure, several issues occurred causing a procedure delay to occur.During the procedure, there were issues with respiration comp which caused irregular movement of the catheter as though movement was related to the regular and irregular breathing pattern.Additionally, there was false space related to incorrect rendering as well as issues with collecting model points in voxel mode.Mid procedure, the patient coughed, and 3 of the prsp became red even though they remained in a fixed position.In order to resolve the issue, the catheter was replaced with an advisor hd grid and respiratory comp was turned off.After these changes were made, the procedure was able to be completed with no adverse patient consequences.
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Manufacturer Narrative
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The event reported catheter movement related to irregular patient respiration and respiration compensation and model bloat.Some of the catheter movement seen was deemed to be actual catheter movement while other motion movement was confirmed to be attributed to respiration.Abbott suggests monitoring the respiration waveform, if the waveform looks regular recollect the respiration compensation baseline.If the breathing pattern is shallow, then consider turning off respiration compensation.If model bloat occurs, the ensite x cardiac mapping system instructions, has several troubleshooting methods outlined for mitigating the issue.
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Search Alerts/Recalls
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