BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Model Number 87035 |
Device Problem
Defective Device (2588)
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Patient Problem
Cardiac Tamponade (2226)
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Event Date 10/07/2022 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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During an ablation procedure, an intellamap orion catheter was selected for use.It was reported that the doctor reported the behavior of the catheter was strange.The device was not deployed, and the light was blinking, though the orion was deployed on the map screen.The electrode was not broken, there was no metal interference, the patch impedance was normal, and the cable was replaced, but the event did not improve.Therefore, the catheter was replaced.After replacing the catheter, the blinking was resolved.In the end, after replacing the catheter, cardiac tamponade was observed in the middle of mapping, so the procedure was canceled because treatment for cardiac tamponade was performed.
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Manufacturer Narrative
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The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Additional information f10/h6 impact codes added f1907: more complex surgery.
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Event Description
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During an ablation procedure, an intellamap orion catheter was selected for use.It was reported that the doctor reported the behavior of the catheter was strange.The device was not deployed, and the light was blinking, though the orion was deployed on the map screen.The electrode was not broken, there was no metal interference, the patch impedance was normal, and the cable was replaced, but the event did not improve.Therefore, the catheter was replaced.After replacing the catheter, the blinking was resolved.In the end, after replacing the catheter, cardiac tamponade was observed in the middle of mapping, so the procedure was canceled because treatment for cardiac tamponade was performed.
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Search Alerts/Recalls
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