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Model Number 45031 |
Device Problems
Display or Visual Feedback Problem (1184); Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993); Pumping Problem (3016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/18/2023 |
Event Type
malfunction
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Event Description
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Reportable based on device analysis completed on 24-oct-2023.It was reported that an error message occurred.The target location was located in the lower extremity vein thrombosis.An angiojet solent omni was used for thrombectomy procedure.During the procedure, an error was observed in the system, and despite multiple attempts to reset the device, the error persisted.It was observed that there was a leak in the pump.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.However, returned device analysis revealed a broken hypotube.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of an angiojet solent omni catheter.The catheter shaft showed multiple bends and kinks.Functional testing was attempted; however, the device would not prime.During analysis at the severely kinked location at 18.2 cm from the tip, the hypotube was broken and completely separated.The device could not be functionally tested due to the extreme damage on the device.No pressure reading was reported before the console would stop the priming process and issue an under-pressure alarm.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for under pressure issues related to a broken hypotube.Kinks were also confirmed.
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Search Alerts/Recalls
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