It was reported during the preparation of watchman procedure to treat nonvalvular atrial fibrillation (a fib), a versacross connect kit was selected for use.Upon opening the dilator, it was noticed that the body of the dilator and the hub were disconnected (photo attached).Hence to resolve the issue, a new kit was opened and the procedure was completed successfully.No patient complications occurred.The device is not expected to be returned for analysis.It was further confirmed, no damages noted to the dilator prior to removing it from the packaging or packaging itself.It is possible the method of removing device caused the issue.The dilator was not re-shaped.The dilator was never assembled with the sheath.It did not become "unsnapped".The plastic dilator body was removed from the grey hub.
|