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Model Number 45029 |
Device Problems
Display or Visual Feedback Problem (1184); Leak/Splash (1354)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/09/2020 |
Event Type
malfunction
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Event Description
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It was reported that an error message occurred: an angiojet pe catheter was selected for use in a thrombectomy procedure.The catheter was attempted be to be primed, but a check saline error message appeared.Priming was attempted again, and the catheter successfully primed.The catheter was advanced to the target lesion, and power pulse mode was activated.However, an error message occurred.The catheter was switched to thrombectomy mode, but another error occurred.It was noted the catheter pump was filled with saline and leaking onto the drawer.The catheter was removed and exchanged for a new angiojet catheter.The new catheter was used to complete the procedure.No patient complications occurred.
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Manufacturer Narrative
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Device evaluated by mfr.: the product return contained an angiojet pe.The assembly, supply line, shaft, saline supply and tip were all visually examined for potential damage.The shaft of the device was separated, leaving a large gap in the aspiration lumen from 25-27 cm on the shaft.A functional test could not be performed due to the damage on the device.
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Event Description
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It was reported that an error message occurred: an angiojet pe catheter was selected for use in a thrombectomy procedure.The catheter was attempted be to be primed, but a check saline error message appeared.Priming was attempted again, and the catheter successfully primed.The catheter was advanced to the target lesion, and power pulse mode was activated.However, an error message occurred.The catheter was switched to thrombectomy mode, but another error occurred.It was noted the catheter pump was filled with saline and leaking onto the drawer.The catheter was removed and exchanged for a new angiojet catheter.The new catheter was used to complete the procedure.No patient complications occurred.
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Search Alerts/Recalls
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