Catalog Number 0998-00-3023-XX |
Device Problems
Bent (1059); Kinked (1339); Difficult to Remove (1528)
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Patient Problems
Calcium Deposits/Calcification (1758); Death (1802); Rupture (2208); Cardiac Tamponade (2226)
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Event Date 12/16/2017 |
Event Type
Death
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.The business unit confirmed that there was no alleged malfunction of the iabp involved in this event.Therefore, no evaluation was needed.This report has been sent per company protocol of co-reporting when the event description entails a serious injury or death regarding the iabp/ iab.The customer confirmed that there was no malfunction with the iabp.There was no further information provided.
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Event Description
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It was reported that cs300 intra aortic balloon pump therapy started on an acute myocardial infarction (ami) patient using the ymt30r-01 catheter.The sheath was difficult to advance.While attempts were made to insert the guide wire it bent and the sheath was being kinked.They were unable to remove the iab and bleeding didn¿t stop so an incision was made to remove the iab.The patient expired the next day by cardiac tamponade due to myocardial rupture.Mild tortuosity, sclerosis and calcification were noted in the patient vessel.There was no alleged malfunction of the cs300.The death is not attributed to the cs300.Related balloon emdr (b)(4).
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Search Alerts/Recalls
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