PERIPHERAL ROTALINK PLUS

Additional Manufacturer Narrative

GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

Description of Event or Problem

IT WAS REPORTED THAT THE BURR WAS STUCK WITH THE WIRE. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED ARTERY. A 2.00MM PERIPHERAL ROTALINK PLUS AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, A PECKING MOTION UPON ADVANCEMENT WAS PERFORMED. HOWEVER, WHILE ATTEMPTING TO REMOVE THE DEVICE, THERE WAS NO WIRE OR DEVICE MOVEMENT AS THE DEVICE WAS BOUND TO THE WIRE. THE BURR AND WIRE WERE REMOVED TOGETHER IN ONE PIECE. THE PROCEDURE WAS PROLONGED AS A RESULT OF THE PROCEDURE. THERE WERE NO COMPLICATIONS REPORTED AND PATIENT IS FULLY RECOVERED.