The device was not returned for analysis. A review of the lot history record and complaint history of the reported lot could not be conducted, because the lot number was not provided. The reported difficulty and subsequent treatment appear to be related to an interaction of the device with patient anatomy or inability to maintain position/stability of the device during deployment due to circumstances of the procedure. 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 additional proglide device is filed under a separate medwatch report number.
Patient Sequence No: 1, Text Type: N, H10
It was reported as a general comment that an arteriotomy closure of common femoral arteries was attempted using proglide devices with a 7f sheath after interventional low leg procedures. Reportedly, when the plungers were removed, there was no suture for all proglide devices. Manual arterial compression was used to achieve hemostasis. There was no adverse patient sequela and no reported clinically significant delay in the procedures or therapies. The number of patients and procedures was not provided. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5