(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.The reported difficulties and subsequent treatment appear to be related to an interaction of the device with patient anatomy due 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.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that an arteriotomy closure of the right common femoral artery was attempted using a proglide device via a 7fr sheath, after a coronary intervention procedure.Reportedly, after the plunger was removed, pulsatile blood flow started again from the marker lumen.The 0.035" guide wire was reintroduced, the proglide device was removed and the sutures were cut.The sheath was reintroduced to stop blood flow.Manual arterial compression was applied to achieve hemostasis.There was no reported adverse patient sequela.There was no reported clinically significant delay in the entire procedure.No additional information was provided.
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