Device evaluated by mfr.: the device was returned for analysis.The shaft, hypotube, tip and balloon were microscopically and visually examined.When received, there was contrast in the inflation lumen.The balloon was tightly folded.There were numerous kinks throughout the hypotube with a complete hypotube separation 74.5cm distal of the strain relief.The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation.Product analysis confirmed the reported shaft kink, as the hypotube had numerous kinks and a complete separation resulting from a kink.However, the reported crossing difficulty could not be confirmed because the clinical circumstances could not be replicated.
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Reportable based on device analysis completed on 13nov2019.It was reported that crossing difficulties and shaft kink were encountered.Vascular access was obtained via the femoral artery.The concentric target lesion with a bend of >= 90 degrees was located in the mildly calcified mid right coronary artery.A 2.50mm x 12mm maverick 2 balloon catheter was selected for use.However, during procedure, it failed to cross the lesion and an acute kinked was noted with the balloon shaft.The procedure was completed with another balloon with the support of guidezilla.There were no patient complications reported and the patient's status was stable.However, returned device analysis revealed shaft detached/separated.
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