A pressurewire aeris was to be used for an ffr measurement.While writing the pressurewire aeris through a torturous left anterior descending artery, it was noticed that the radiopaque tip of the pressurewire got kinked in the lad.Thus, the pressurewire was removed and the radiopaque tip was found entirely unraveled.A new pressurewire was used to finish the procedure.
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No evidence of externally induced markings (like scratching), inherent weak spots (like inclusions) or flaws from the manufacturing process that could have contributed to the fracture were found on the core wire.From the visual examination and analysis of sem images, it is likely that the initial bending followed by rotational/shear load caused the failure.Fracture surface features indicate that the fracture occurred mainly by ductile mechanism which is expected for this material (stainless steel grade 304).A review of the device history record confirmed that the device was manufactured according to sjm specification.Ifu text extracts: excessive manipulation when sensor element or tip of pressurewire is located in sharp bend may cause damage or tip fracture.Torquing pressurewire against resistance or repeated attempts to cross a total vessel occlusion may cause damage and/or fracture, which may lead to a portion of pressurewire separating from the tip.Never push, withdraw or torque pressurewire if it meets resistance.
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