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.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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It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system, and a map shift occurred with no patient movement or cardioversion with no error message issue occurred.It was reported that there was a map shift noticed late in the procedure.They was no apparent patient motion or cardioversion with no errors on the carto 3 system.The physician had to use the map to complete the procedure.It was too late into the procedure to remap.There was no report of patient consequence.The reported map shift with no patient movement or cardioversion with no error message populating, was assessed as a reportable mdr malfunction.
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On 7/6/2020, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system, and a map shift occurred with no patient movement or cardioversion with no error message issue occurred.It was reported that there was a map shift noticed late in the procedure.They was no apparent patient motion or cardioversion with no errors on the carto 3 system.The physician had to use the map to complete the procedure.It was too late into the procedure to remap.There was no report of patient consequence.Device investigation details: the data related to the reported issue was investigated by htc (investigation request # (b)(4)).It was found that the locating of fluoro system too close to location pad electromagnetic field caused high metal distortion on the back patches, which affected the body coordinate system (bcs) correction between chest and back patches, and consequently caused it to map shift.It was also confirmed that the system showed error 256, and informed user that the patient body reference (back patches) has changed position and cannot be compensated by the system and can lead to map shift.The issue was related to user error.Fse confirmed that the technical service was offered to the user to check the system, but it was declined.User continues to use the system.The history of customer complaints reported during the last year associated with carto 3 system #: (b)(6) was reviewed.No similar complaints were found there out of 20 additional complaints.A manufacturing record evaluation was performed for the 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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