The returned q6 device was received in two (2) separate pieces fully traceable with mivi lot number.No additional components were received for analysis.Distal shaft appeared normal, distal end not damaged, proximal edge (where catheter segment and push wire attach) was split and displayed physical damage.Based on device analysis and type of damage, the most likely scenario for the push wire detachment is that the proximal edge of the q6 tubular segment either interacted with just the distal tip of the guide catheter or with the distal tip of the guide catheter in conjunction with a guidewire.This interaction caused damage resulting in a separation of the push wire from the tubular segment.The type of damage is indicative of the device being retracted while experiencing excessive resistance.Accessory devices were not returned for analysis.Manufacturing records for the device lot did not reveal any outstanding discrepancies, design, or quality records issues.(b)(4).
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