(b)(4).The device was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the treatment appears to be related to circumstances of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The other three proglide devices are filed under separate medwatch manufacturing report numbers.
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It was reported that an arteriotomy closure of a common femoral artery, with no significant calcification, was attempted using four proglide devices with a 6f sheath after an interventional cerebral stenting procedure.Reportedly, during knot advancement, the knot locked and the suture broke for all four devices.No excessive force was applied; the sutures looked frayed after removal.Manual arterial compression was used to achieve hemostasis.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
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