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Model Number 45007 |
Device Problems
Failure to Prime (1492); Suction Problem (2170)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device eval.By manufacturer: upon receipt at our post market quality assurance laboratory, this 2.4mm jetstream xc atherectomy catheter was visually and microscopically examined.Visual examination revealed a hole in the aspiration line.Microscopic examination revealed no additional damages.Functional testing was performed, and the device was able to prime.When the device was ran it was unable to aspirate.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Product analysis confirmed the failure to evacuate due to the hole in the aspiration line.
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Event Description
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Reportable based on device analysis completed on 22apr2021.It was reported that the catheter would not prime of aspirate.A 2.4mm jetstream xc was selected for use in an atherectomy procedure.The device was set up according to the instructions for use.However, upon priming the healthcare professional (hcp) found the aspiration function of the catheter was not working.The hcp set-up the device again and the issue persisted.The procedure was completed by using a different jetstream catheter.The catheter was not inserted in patient and there was no harm to the patient.However, device evaluation revealed there was a burst in the infusion line.
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Search Alerts/Recalls
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