BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) CARTO® 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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Model Number M-4800-01 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Device Overstimulation of Tissue (1991)
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Event Date 05/15/2014 |
Event Type
malfunction
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Event Description
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It was reported that during an ablation procedure with the use of the carto 3 system, there was a stimulation problem.To resolve the issue, they exchanged the body surface (bs) cable and the stim cable.There was no patient injury reported in this procedure.Upon request, additional information was provided on (b)(6) 2014.Pacing was used to induce arrhythmia.It was impossible to pace through all the patient interface unit ports which included the emergency or direct pacing ports of the carto 3 system.There was no error.All cables were connected as usual.In order to pace, the user had to connect the catheter on the ep bard recording system directly.They tried to stimulate after the ablation, not during.The stimulator being used was the micropace.Pacing on the ep bard recording system was correctly configured.Per the additional information received on (b)(6) 2014 stating that the pacing was not possible with the emergency/direct pacing port, this issue is indicative of a reportable event.Marking (b)(6) 2014 as the awareness date for this report.
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Manufacturer Narrative
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Investigation still in progress.A supplemental report or device evaluation will be submitted.Manufacturer's ref.No: (b)(4).
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Manufacturer Narrative
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Manufacturer's ref.No: (b)(4).It was reported that during an ablation procedure with the use of the carto 3 system, there was a stimulation problem.It was impossible to pace through all the patient interface unit ports which included the emergency or direct pacing ports of the carto 3 system.There was no error.All cables were connected as usual.In order to pace, the user had to connect the catheter on the ep bard recording system directly.They tried to stimulate after the ablation, not during.The stimulator being used was the micropace.Pacing on the ep bard recording system was correctly configured.To resolve the issue, they exchanged the body surface (bs) cable and the stim cable.There was no patient injury reported in this procedure.A broken pacing cable caused the issue.The cable was replaced with another one, and as a result, the issue was resolved.Also, the bs ecg cable was replaced as it was broken.However, the broken bs ecg cable was not related to the pacing problem.The history of customer complaints associated with carto 3 system # 11195 was reviewed.Three out of twenty additional reported complaints, may be related to the reported issue.A device history record (dhr) review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.
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