Catalog Number FG540000M |
Device Problem
Image Orientation Incorrect (1305)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).
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Event Description
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It was reported a patient underwent a procedure with a carto 3 system and a map shift issue occurred.It was reported that after the epicardium and both ventricles had been mapped, a significant map shift occurred with no error messages on the carto 3 system.There were eo error message was displayed, no metal interferences and no change of any of the back patches' locations.The map shift was discovered since the sensor enabled catheter appeared outside the acquired geometry and described as somewhere between 1 cm and 3 cm shift.There was no patient movement or cardioversion prior to the shift.The chambers were remapped in order to continue the case.There were no patient consequences.This is event has been assessed as mdr reportable.
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Manufacturer Narrative
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On 11/6/2018, the manufactured date of the carto 3 system was received.Therefore, device manufacture date has been populated with 6/16/2011.Manufacturer's ref # (b)(4).
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Manufacturer Narrative
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It was reported a patient underwent a procedure with a carto 3 system and a map shift issue occurred.It was reported that after the epicardium and both ventricles had been mapped, a significant map shift occurred with no error messages on the carto 3 system.There were no error messages displayed, no metal interferences and no change of any of the back patches' locations.There was no patient movement or cardioversion prior to the shift.Device evaluation details: it was reported that the biosense webster inc.(bwi) representative and bwi field service engineer were informed about this issue, but no action was taken since the case was successfully completed.It was also confirmed that no similar issue has been reported since then.The system is operational.A device history record (dhr) review was performed by the manufacturer and no anomalies, which are related to the reported issue, were noted in manufacturing or servicing of this equipment.Manufacturer ref # (b)(4).
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Search Alerts/Recalls
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