The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device is expected to be returned.The investigation is on-going.
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It was reported that the device became stuck in a 6fr cook ansel sheath during advancement into the lesion.The doctor prepped the device.There were no anomalies noted during the prep of the device.There was no damage noted to the box, tray or stent cover and no difficulty removing the stent cover.The patient was being treated for sma stenosis mesenteric ischemia.A 6f, 45 cm ansel 2 introducer sheath and a 0.035, 260 cm rosen guidewire were used.The device was attempted to be inserted through the 6f sheath however resistance was felt just past the valve of the sheath.An attempt was made to retract the device from the sheath however this was unsuccessful as the stent was stuck.The stent remained stuck in the introducer sheath.Air evacuation was not performed prior to inserting the device.Multiple attempts to insert the device were not made.There was no reported patient injury.However, the access site was lost.
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