It was not possible to advance a ado size 3, from the loader to the apropriate 5f ds.Everything had to be changed to a 6f ds.The 6f ds was to big to cross the pda (very narrow at the pulmonary artery size) the ado (mounted in the cable) was back loaded in the initial 5f ds to test the ds inner diameter.It was possible to pull in the device and to pull it outfrom the ds hub the cardiologist concluded the problem was the connection between the loader and the ds.The loader screw was cut out.The 5f ds was again inserted in the patient.The cardiologist did a "direct connection" of the cut loader with the ds, and advanced.The ado into the ds under constant manual saline flush to avoid ar coming in.The ado was correctly implanted.
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Additional information sections: b5, d10, h2, h3, h6, h10.An event of difficulty advancing the occluder into the sheath could not be confirmed.The investigation confirmed the device met dimensional and functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.
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