Catalog Number IAB-05840-LWS |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The sample was discarded and will not be returned for investigation.
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Event Description
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It was reported via a hot line call.The rn from the ccu called the clinical support specialist and stated that during an insertion, the iab was inserted normally via the femoral artery without difficulty.After placement the guidewire would not withdraw from the catheter.The catheter and sheath were removed and a second iab was inserted without difficulty.The patient was then supported on the iabp.The rn told the css that this was not a current incident.
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Manufacturer Narrative
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(b)(4) no product was returned for evaluation.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of swg removal difficult is not able to be confirmed.No product was returned for evaluation.The root cause of the complaint is undetermined.
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Event Description
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It was reported via a hot line call.The rn from the ccu called the clinical support specialist and stated that during an insertion, the iab was inserted normally via the femoral artery without difficulty.After placement the guidewire would not withdraw from the catheter.The catheter and sheath were removed and a second iab was inserted without difficulty.The patient was then supported on the iabp.The rn told the css that this was not a current incident.
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Search Alerts/Recalls
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