Model Number 45031 |
Device Problem
Break (1069)
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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 01/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event - used the first day of the month of the aware date since no exact date provided.
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Event Description
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It was reported that catheter break occurred.The target lesion was located in the superior mesenteric artery (sma).An angiojet solent omni catheter was selected for a thrombectomy procedure.The catheter was advanced beyond the thrombus in the sma.During procedure, a loud pop was heard and found that the catheter was broken.The procedure was completed with a different device.No patient complications were reported.
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Event Description
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It was reported that catheter break occurred.The target lesion was located in the superior mesenteric artery (sma).An angiojet solent omni catheter was selected for a thrombectomy procedure.The catheter was advanced beyond the thrombus in the sma.During procedure, a loud pop was heard and found that the catheter was broken.The procedure was completed with a different device.No patient complications were reported.
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Manufacturer Narrative
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B3 - date of event - used the first day of the month of the aware date since no exact date provided.G1 - manufacturing address corrected.Device evaluated by mfr.: returned product consisted of an angiojet solent omni catheter.The pump assembly, effluent/supply line, shaft, tip and spike line were visually examined for damage or any irregularities.The shaft showed 1 kink located 64.5cm from the tip.Functional testing was competed per device preparation.The pump was inserted into the ultra drive unit console.The pump and device primed and was run for a period of 120 seconds in the thrombectomy mode.The devices pressure was within the normal range.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.
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Search Alerts/Recalls
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