It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a carto 3 system, and during mapping a silent map shift issue occurred twice.The initial map shift occurred post cardio-version while evaluating the patch positions.A new map was created as the shift was significant.The initial observed map shift has been assessed as not reportable as this is a normal expected response from the system.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The second map shift occurred mid-way into a re-map as it was noticed that the locations were off.Map shift was observed during catheter manipulation as it appeared outside of the already created map.The approximate difference in catheter location before and after map shift was approximately 1-2 cm.No system errors or alerts were observed.No adverse patient consequences were reported.The second observed map shift issue has been assessed as mdr reportable.
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It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a carto 3 system, and during mapping, a silent map shift issue occurred twice.The investigational analysis completed 3/12/2019.The biosense webster inc.(bwi) field service engineer (fse) advised that the map shift issue be reported for documentation purposes.However, no service was requested.System is functional and ready for use.The map shift had not returned in later case.According to carto 3 instructions for use, when the relative position between the patches remains the same but the position of the heart relative to the back patches has changed (for example, after repositioning the patient's head on a pillow or moving the patient's arm without changing the patient's position on the mattress, or after the patient has cardioverted), the system will not give a warning and an incorrect map (map shift) might be generated.Device history record 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.On 3/14/2019 additional information was provided indicating the device manufacture date of: 3/1/2017.Manufacturer ref no: (b)(4).
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