It was reported that during device preparation, the three-way stopcock was attached to the flush port on the steerable guide catheter (sgc); however, when the sgc was turned upside down to advance on the guide wire, the stopcock fell off.In order to use the device, sutures and tape were used to secure the stopcock in place.The sgc was used in the mitraclip procedure without further incident.Two clips were successfully implanted and mitral regurgitation (mr) was reduced from grade 4 to 2.No additional information was provided.
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(b)(4).The device was returned and investigated.The reported loose/intermittent connection was unable to be confirmed.The returned stopcock, as well as a proxy stopcock, were tightened onto the sgc flush port with no issues.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.The mitraclip system instructions for use warns, do not use if damage is detected.Use of damaged product may result in air embolism, vascular and/or cardiac injury.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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