Product analysis: the inpact admiral device was returned to medtronic investigation lab for evaluation.The device was returned with a guidewire entrapped in the device and a detachment at the shaft of the complaint device with the detached portion of the shaft and balloon entrapped in a non-medtronic sheath.Multiple sites of deformation were evident to the shaft of the device.Balloon bunching was evident immediately distal to the distal tip of the sheath with some fluid evident in the balloon.Slight deformation was present to the distal tip consistent with use of the device.The sheath was cut, and the entrapped section of the device was removed.The balloon folds were open.Multiple dents were evident to the shaft.A 0.035inch guidewire was loaded via the distal tip but was not possible to advance through the device due to the detachment and damage.Device removal recreation was not possible due to entrapment of the device in the sheath.If information is provided in the future, a supplemental report will be issued.
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