Device evaluated by mfr: the device was returned for analysis.Device analysis revealed a kinks was observed in the telescope assembly from femoral marker to the proximal end, however, the catheter did not present any kinks in the sheath assembly.The telescope assembly was not able to properly pull back, advance, and retract, due to the returned condition of the catheter.No other 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 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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