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Catalog Number IAB-S840C |
Device Problem
Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported during insertion of the intra-aortic balloon (iab) "the guide does not advance through the light of the ball, it is finally possible to advance and positioned properly, but the ball does not give the pressure wave, despite washing several times the internal light and advancing the guide there is no wave or pressure record, so it is decided to change the iab." there was no patient death or serious injury or reported.
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Manufacturer Narrative
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Qn# (b)(4).Teleflex received the device for investigation.The reported complaint that the "guide does not advance" is confirmed.Upon inspection, the central lumen was found damaged with kinks.Upon inserting a guidewire, resistance was experienced at the location of the kinks.The root cause of the kinks 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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Event Description
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It was reported during insertion of the intra-aortic balloon (iab) "the guide does not advance through the light of the ball, it is finally possible to advance and positioned properly, but the ball does not give the pressure wave, despite washing several times the internal light and advancing the guide there is no wave or pressure record, so it is decided to change the iab." there was no patient death or serious injury or reported.
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Search Alerts/Recalls
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