This complaint was reported by getinge's corporate medical affairs manager via an article in the 22nd annual scientific meeting, hfsa s119 / s120 journal of cardiac failure vol.24 no.8s august 2018.As follows: after 13 days of intra-aortic balloon pump (iabp) therapy on an unknown iabp, a (b)(6) male with end stage heart failure on a bridge to transplant experienced abdominal pain, nausea, and vomiting.The intra-aortic balloon catheter (iabc) was by percutaneous axillary insertion and an abdominal ct scan showed the intra-aortic balloon catheter (iabc) tip and distal segments in sma (superior mesenteric artery).The iabc was exchanged and the pain was resolved.Percutaneous axillary insertion of getinge's iabcs' are off-label use.The article did not provide any information on whether the balloon pump in use at the time was a maquet/getinge intra-aortic balloon pump or allege a malfunction thereof of the involved iabp; however, the event site is a getinge account.A getinge service territory manager (stm) contacted the customer and was advised that no patient information or further event details was available.A separate report was submitted on the iabc suspected to be involved in this event under medwatch #2248146-2018-00651.
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