Device evaluation: the visual appearance of the balloon showed an evident twist 4 cm from the tip.After the decontamination visual and tactile inspection were performed: it was found unfolded, full of dried contrast medium.It was impossible to load the 0,018'' guide wire since the guidewire lumen was blocked by dried blood.The balloon was inflated and observed under microscope: - 2 bar: it was showing wrinkles on the surface and a constriction in correspondence of the twisted area - 7 bar and 14 bar: wrinkles were no more detected.No twist was present on the guide wire lumen.Once deflated the balloon still showed slight wrinkles at the twisted area.Root cause is related to the direction of the folding pleats which appear not to be folded parallel to the shaft of the device.Once inside the artery, the folding pleats most likely encounter resistance related to a tight lesion, resulting an incomplete balloon expansion evaluation codes: conclusion: operational context caused or contributed to event - the root cause is related to the direction of the folding pleats which appear not to be folded parallel to the shaft of the device.Once inside the artery, the folding pleats most likely encounter resistance related to a tight lesion, resulting an incomplete balloon expansion.
|
Physician was attempting to treat a lesion in the sfa using in.Pact pacific, it was reported that during inflation, twist in the balloon was noted.Another in.Pact pacific was used to complete the procedure.No injury to patient.¿please note that this device (in.Pact pacific) is not marketed in the united states; however, it is similar to the united states marketed device (in.Pact admiral).This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.¿.
|