Catalog Number IAB-06840-U |
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 12/19/2017 |
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 that the intra-aortic balloon (iab) catheter wouldn't pass over the wire.As a result, the iab was not used.Another attempt at the procedure was made with another iab and was successful.There was no delay or interruption in therapy and no patient complications.No reported death or serious injury.
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Manufacturer Narrative
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Qn# (b)(4).Teleflex received the device for investigation.The reported complaint that the iab "wouldn't pass over the wire" is confirmed.The returned iab was found kinked and the central lumen was broken at this location.A bend was also noted to the central lumen in another location.The damaged central lumen caused guidewire insertion difficulty.A definitive root cause of the bend/kink could not be determined but the damage potentially occurred while removing the iab from the tray.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 issue 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 that the intra-aortic balloon (iab) catheter wouldn't pass over the wire.As a result, the iab was not used.Another attempt at the procedure was made with another iab and was successful.There was no delay or interruption in therapy and no patient complications.No reported death or serious injury.
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Search Alerts/Recalls
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