BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Lot Number 0028751790 |
Device Problems
Leak/Splash (1354); Device Contamination with Body Fluid (2317)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/27/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a cryo ablation procedure to treat atrial fibrillation using a polarsheath blood was leaking from the side port.Ablations were completed on the left superior pulmonary vein, then the left inferior pulmonary vein, next the right superior pulmonary vein, and finally during ablation of the right inferior pulmonary vein blood was noticed to be leaking from the side port of the sheath.As the issue was noticed during the final ablation, the procedure was considered completed.There were no patient complications.The sheath has been received for analysis.
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Event Description
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It was reported that during a cryo ablation procedure to treat atrial fibrillation using a polarsheath blood was leaking from the side port.Ablations were completed on the left superior pulmonary vein, then the left inferior pulmonary vein, next the right superior pulmonary vein, and finally during ablation of the right inferior pulmonary vein blood was noticed to be leaking from the side port of the sheath.As the issue was noticed during the final ablation, the procedure was considered completed.There were no patient complications.The sheath has been received for analysis.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, the sheath was functionally tested by replicating asperation as it would happen in the field.The sheath failed asperation testing as air was visible in the flush line each time the syringe was drawn back.Next, they tested the ability of the sheath's valve to maintain pressure, and the device failed to maintain the minimum acceptable internal pressure.They then identified the location of the leaks by flushing the lure while the distal tip was plug.The leak was identified as coming from the hemostatic valve, as fluid came from the valve during this flush testing.The allegation in the complaint was confirmed as testing identified a leak in the hemostatic valve.The cause was determined to be component failure due to the failure of the valve.
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Search Alerts/Recalls
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