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Catalog Number IAB-S840C |
Device Problems
Complete Blockage (1094); No Device Output (1435)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (b)(4).
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Event Description
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It was reported that after the intra-aortic balloon (iab) catheter was implanted, no pressure waveform was found.The pressure transducer was replaced, but no improvements.As a result, a new catheter was used, and the pressure waveform was restored to normal.There was no report of patient complication or serious injury and death.
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Event Description
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It was reported that after the intra-aortic balloon (iab) catheter was implanted, no pressure waveform was found.The pressure transducer was replaced, but no improvements.As a result, a new catheter was used, and the pressure waveform was restored to normal.There was no report of patient complication or serious injury and death.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for the reported complaint.The reported complaint of iab central lumen occluded is confirmed.The aspi ration/flushing test was successful; however, a kink was noted to the central lumen and is the potential cause of the reported complaint.The root cause of the kinked central lumen is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This will be monitored for any developing trends.No further action required at this time.
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Search Alerts/Recalls
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