Model Number M004CRBS3050 |
Device Problems
Leak/Splash (1354); Material Integrity Problem (2978)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/20/2020 |
Event Type
malfunction
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Event Description
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It was reported that a polarsheath was selected to be used in a procedure.During preparation when the physician was flushing and aspirating saline through the sheath, bubbles were being pulled into the syringe.Upon inspecting the sheath it was noted that the side port looked damaged.No patient complications were reported.
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Event Description
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It was reported that a polarsheath was selected to be used in a procedure.However during preparation when the physician was flushing and aspirating saline through the sheath bubbles were being pulled into the syringe.Upon inspecting the sheath it was noted that the side port looked damaged.No patient complications were reported.
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Manufacturer Narrative
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Visual inspection of the device showed the had a puncture not connected to the slit.There was a crimp/kink in the irrigation flush line.The device did not pass hemostasis at 5.5 psi pressurization with saline, and aspiration with 10 cc and 60 cc syringes at various flowrates.Air pressure testing was performed to identify the location of any potential leaks.The device was gently pressurized at the flushing line luer fitting while plugging the distal tip of the catheter.No air bubbles were observed but the pressure decay measurements were out of specification indicating a leak from the sheath's hemostatic valve.There is no evidence this device was used in a manner inconsistent with the labeled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
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Search Alerts/Recalls
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