As reported, the balloon of a 6/7f mynx control vascular closure device (vcd) burst during prep.Therefore, the product was not available and manual compression was performed for twenty minutes and recovered.There was no reported patient injury.There were no visible signs of device/package damage prior to use.The mynx control vessel closure unit was prepared and used in accordance with instructions for use (ifu) instructions.The femoral artery¿s suitability was verified on angiography or venography including the insertion angle (30-45 degrees) of the 6f non-cordis vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was no vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.The mynx vcd used in transfemoral cerebral angiography (tfca) with a retrograde approach.The physician achieved certification on the use of mynx and has used the device several times prior to this procedure.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.
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