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Model Number FG540000 |
Device Problems
Computer Software Problem (1112); 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 01/11/2022 |
Event Type
malfunction
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Event Description
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It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto 3 system.There was a map shift.When using cartosound, fast-anatomical mapping (fam), and cartomerge, it was observed that the map on the carto 3 system had shifted, and the catheter location was no longer where it used to be.There were no error messages or alerts displayed on the carto 3 system, but the map had shifted by about 4cm.The physician was concerned, and the lasso catheter was replaced with a pentaray catheter.They built a new left atrium fam map with the pentaray catheter, but the map was still off by about 4cm.Then it was reported that the carto 3 system displayed error 1104--there is not enough free memory.It was also reported that at this point the ablation catheter and the pentaray catheter were jumping all over the screen.The team rebooted the carto 3 system workstation, continued the same study, and then noticed that the previous cartomerge map appeared normal and accurate, but the new map they had done with the pentaray catheter was still off.They then used the same lasso catheter as before, instead of the pentaray catheter, and the procedure continued using the original map.The map shift was discovered when the ep was ablating and observed the catheters were no longer contacting the fam or ct in the same spots and intracardiac echo (ice) confirmed the change in location.The issue was seen during ablating.The approximate difference in catheter location before and after map shift was 3-4 mm.The physician did not perform cardioversion prior to the map shift and the patient did not move before detecting the shift.The workstation issue is not mdr-reportable.The map shift is mdr-reportable.
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Manufacturer Narrative
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The hardware investigation has begun but it has not been completed at this time.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Manufacturer Narrative
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On 27-jul-2022, the product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto 3 system.There was a map shift.Device evaluation details: the data was requested for investigation, but no data related to the issue was not provided, according to bwi company representative the data is no longer available.As result, it was not possible to reproduce or analyze the issue.The root cause of the reported map shift issue was not determined.Bwi company representative rebooted the workstation and used a default template.This resolved the issue.System is up and ready for use.A manufacturing record evaluation was performed for the carto 3 system # (b)(6), and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Search Alerts/Recalls
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