Catalog Number IAB-S840C |
Device Problem
Insufficient Information (3190)
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Patient Problems
Atherosclerosis (1728); Cardiogenic Shock (2262)
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Event Date 05/27/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Sample not expected to be returned.
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Event Description
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It was reported that while in the cath lab the iab was inserted via the patient's femoral artery.During use there was an occurrence and as a result the iab was removed and replaced.There was no reported patient death, injury or complications.There was no delay or interruption in iabp therapy.
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Manufacturer Narrative
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(b)(4) additional information received on 07/18/2016.The occurrence was blood in the helium pathway, and as a result the iab was removed and replaced.The second iab was inserted via the same insertion site, right femoral artery via a sheath.There was a 10 minute delay / interruption in iabp therapy.The procedure was successful.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 blood in helium pathway is not able to be confirmed.No product was returned for evaluation.The root cause of the complaint is undetermined.If the sample is returned at a later date, a full investigation will be completed.
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Event Description
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It was reported that while in the cath lab the iab was inserted via the patient's femoral artery.During use there was an occurrence and as a result the iab was removed and replaced.There was no reported patient death, injury or complications.There was no delay or interruption in iabp therapy.
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Search Alerts/Recalls
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