This is filed to report that during use with the steerable guiding catheter (sgc), the stopcock would not stay tightened on the sgc flush port and if were to reoccur in the patient anatomy, has the potential to cause or contribute to patient injury.It was reported that after the steerable guiding catheter (sgc) was prepared for use, the femoral skin was dilated, and the sgc was advanced, but it was found that the stopcock would not stay tightened on the sgc flush port.Three separate stopcocks were attempted, but would not tighten.The sgc was never inserted into the anatomy, and was replaced.A new sgc was successfully used with one of the previously attempted stopcocks.There was no clinically significant delay in the procedure.No additional information was provided.
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(b)(4).Evaluation summary: the steerable guide catheter (sgc) was returned and investigated.The reported loose/intermittent connection was unable to be confirmed.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.All available information was investigated and the reported loose/intermittent connection is possibly related to variation in the non-abbott stopcocks used at the account; however, this cannot be definitively determined.The returned device analysis confirmed that the sgc flush port functioned as expected.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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