It has been reported that a versacross connect laac access solution kit was selected for use for a watchman left atrial appendage closure (laac) procedure.The physician normally uses the versacross rf wire as a starter wire.However, this patient had pacemaker leads, and it was decided to advance with the mechanical guidewire.After the wire was anchored into the superior vena cava (svc), the physician advanced the connect dilator and watchman sheath up to the svc.The mechanical guidewire got stuck in the dilator when he attempted to retract the wire out of the patient.Ultimately, both the connect dilator and mechanical guidewire were removed together out of the watchman sheath.In addition, the dilator tip was reported to be found damaged/defective after it was removed, it was manually reshaped but not to an excessive degree.The guidewire was exposed to the patient when it got stuck during withdrawal.No damaged was noted on the guidewire after removal from the body or prior to insertion.Next, the physician inserted the versacross rf wire into the svc and loaded a new versacross connect dilator into the watchman sheath over it.The procedure was completed successfully.No patient complications reported.Product is not expected to return as it was disposed of at the facility.It was also mentioned that the dilator tip was damaged.
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