(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and a definitive cause for the reported mechanical issue of loss of tip deflection and noise could not be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.
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This is filed to report inability to deflect the steerable guide catheter (sgc) tip.It was reported that after the sgc was prepared for use, the minus knob was applied in order to insert the sgc into the femoral vein; however, a crack was heard and the sgc could no longer be straightened.The device was not used and was replaced.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
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