Intra-aortic balloon ruptured/failed while in use inside a patient's aorta, connected to an intra-aortic balloon pump.Because the patient was dependent on the support of the balloon pump to sustain life, the patient needed to have an emergent procedure to replace the balloon.Fda safety report id # (b)(4).
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Additional information received from a reporter on 06/10/2022 for a report number mw5110227.Of note, this event occurred 2 times on the same patient.The balloon was placed (b)(6) 2022, ruptured (b)(6) 2022, replaced with new (b)(6) 2022, ruptured again on (b)(6) /2022, replaced again with a new one on (b)(6)2022.(second medwatch report filed for the (b)(6) 2022 event).Common cause analysis found that the balloon was placed through the axillary artery, which is an approved, however, atypical insertion site.Also the patient was more physically active than what is typical of patients on an intra-aortic balloon pump, as he need to engage fully with physical therapy while waiting for a heart and kidney transplant.
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