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 01/19/2018 |
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 intra-aortic balloon (iab) insertion on a patient the medical doctor tried to pass the guidewire through the catheter.However, the catheter could not be passed over the guidewire.The md could not proceed with the procedure.As a result, the medical doctor removed the device and replaced it with a new set successfully.There was no delay/interruption in therapy.No patient complications and no reported patient death or serious injury.No medical intervention required.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of iab tight over guidewire is confirmed.Upon return, the iab had a 0.025in guidewire partially inserted through the iab distal tip; the guidewire remained stuck in the central lumen.Upon further inspection, the location of resistance to the central lumen was found damaged with kinks and flattened features.The root cause of the damage to the central lumen is undetermined but a potential cause is a result of customer handling.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 device.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 intra-aortic balloon (iab) insertion on a patient the medical doctor tried to pass the guidewire through the catheter.However, the catheter could not be passed over the guidewire.The md could not proceed with the procedure.As a result, the md removed the device and replaced it with a new set successfully.There was no delay/interruption in therapy.No patient complications and no reported patient death or serious injury.No medical intervention required.
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Search Alerts/Recalls
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