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 investigation was unable to determine a conclusive cause for the reported difficulties; however, the treatment appears to be related to circumstances of the procedure. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10
It was reported that an arteriotomy closure of a common femoral artery was attempted using a starclose se device with a 6f sheath after an interventional low leg procedure. Reportedly, the starclose se device did not achieve hemostasis. 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.
Patient Sequence No: 1, Text Type: D, B5