Description of Event or Problem · 1
REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: PARTIALLY DEFLATED BALLOON IS LIKELY TO CAUSE OR CONTRIBUTE TO PT INJURY. DEVICE ISSUE: PARTIALLY DEFLATED BALLOON. IT WAS REPORTED THAT AFTER PREDILATATION OF THE DISTAL RCA WITH A VOYAGER, THE LESION WAS STENTED WITH A VISION. POST DILATATION WAS PERFORMED AT NOMINAL PRESSURE (10 ATM) WITH A POWERSAIL. AT THE FIRST INFLATION, NO CONTRAST WAS SEEN; THEREFORE, IT WAS UNCERTAIN WHETHER THE BALLOON HAD FULLY INFLATED. UPON THE SECOND INFLATION, CONTRAST WAS VISIBLE AND POST DILATATION WAS PERFORMED. AFTER POST DILATATION, THE BALLOON DID NOT DEFLATE. AN INDEFLATOR WAS USED TO RE-INFLATE THE BALLOON, AS IT WAS UNCERTAIN IF THE BALLOON HAD BEEN INFLATED ENOUGH. THE BALLOON WAS BROUGHT UP TO 10 ATM TWICE, BUT STILL UNABLE TO DEFLATE. A 20 CC SYRINGE WAS THEN USED ON THE STOPCOCK TO ADD ADDITIONAL PRESSURE. THE BALLOON WAS ABLE TO BE DEFLATED ENOUGH TO REMOVE FROM THE VESSEL. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL EVENT OR PATIENT INFO IS AVAILABLE.