Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr.: returned device consisted of a coyote es balloon catheter with blood and contrast in the inflation lumen.The balloon was loosely folded.The balloon, markerbands, proximal weld and inner/outer shafts were microscopically and tactile inspected.Inspection revealed tip damage and a pinhole in the balloon material over the markerband.Functional testing was performed by connecting an inflation device filled with water to the hub.When pressure was applied, water was found to be leaking from the balloon.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).
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Reportable based on device analysis completed on 20-jun-2018.It was reported that crossing difficulties were encountered.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified vessel below the knee.After a guide wire crossed the lesion, a 1.5mm x 20mm x 143cm coyote¿ es balloon catheter was advanced but failed to cross the lesion.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed balloon pinhole.
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