The device was not returned for analysis.A review of the lot history record and similar incident review could not be conducted because the lot number was not provided.It is possible that the clamp seal was not entirely closed; thus, resulting in the reported leak; however, as the device was not returned for analysis this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The other copilot device referenced is filed under separate medwatch report number.
|
It was reported that during the procedure, air bubbles were noted going from the copilot to the guide when injecting contrast into the artery.Another copilot was used to continue the procedure without consequence, but the same thing occurred.There was no adverse patient effect and no clinically significant delay in the procedure.Another device was used to continue the procedure.No additional information was provided.
|