Model Number M004CRBS3050 |
Device Problems
Leak/Splash (1354); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/25/2022 |
Event Type
malfunction
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Event Description
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It was reported that a polarsheath was used in a atrial fibrillation catheter ablation procedure.During the procedure after the device was inserted inside the body, and when asperation was performed after removing the dilator, air was observed and the physician suspected that there was an issue with the hemostatic valve.The catheter was exchanged and the procedure was completed with no patient complications.
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Manufacturer Narrative
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Visual inspection of the device showed blood on handle and in sheath.The sheath did not present any issues related to flow or leakage.There weren't any signs that the uncontrolled tear on the surface would cause any leaks.The sheath passed aspiration, hemostasis valve and air pressure tests.It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.
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Event Description
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It was reported that a polarsheath was used in a atrial fibrillation catheter ablation procedure.During the procedure after the device was inserted inside the body, and when asperation was performed after removing the dilator, air was observed and the physician suspected that there was an issue with the hemostatic valve.The catheter was exchanged and the procedure was completed with no patient complications.
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Search Alerts/Recalls
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