Reportable based on device analysis completed on 17dec2014.It was reported that the shaft of this device was kinked.During a procedure, an opticross imaging catheter was used to diagnose as unknown target lesion.The shaft of this device was kinked during preparation.The device was exchanged to another of same device to complete the procedure.No patient complications reported and the patient's condition is good.However, device analysis revealed that the device has a lap joint separation with leaks.
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(b)(4).The device was returned for evaluation.Examination of the returned device revealed a kink in the sheath assembly at 3.5 cm, in the proximal femoral marker at 0.01cm, in the sheath assembly at 22.5 cm, and in the imaging window assembly at 101cm and 104cm.Fluid was leaking from the lap joint separation, 75 cm from the femoral marker at the distal end when the catheter was flushed.Imaging core wind up in the telescope assembly was observed during visual analysis.Impedance testing shows an electrical open at proximal wave form.No issues or defects were observed during product analysis of the returned device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
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