OUS MDR - A 70%, SEVERELY CALCIFIED STENOSIS IN THE LEFT ILIACA COMMUNIS WAS TREATED, AND THE ACCESS WAS MADE VIA THE RIGHT FEMORAL ARTERY IN CROSSOVER. THE PASSEO-35 WAS INFLATED TWICE, ONCE WITH A 10-ML AND ONCE WITH A 2-ML OMNIFIX SYRINGE, FOR 30 S. DURING THE LAST INFLATION WITH THE 2-ML SYRINGE, THE BALLOON BURSTS, AND CONTRAST AGENT REMAINS IN THE TIP OF THE BALLOON. DURING RETRACTION, THE BALLOON GOT PUSHED UP ONTO THE DISTAL TIP, AND IT COULD NOT BE REMOVED THROUGH THE 5F SHEATH. THE BALLOON CATHETER WAS TORN OFF. THE 0.035" GUIDE WIRE WAS REMOVED ACCIDENTALLY. A SUBSEQUENT RETRIEVAL MANEUVER WITH A NOOSE REMAINED UNSUCCESSFUL. A NEW 0.035" GUIDE WIRE WAS BROUGHT IN. THE WIRE WAS INTRODUCED DOUBLED, A NOOSE WAS FORMED, AND WITH IT, THE DISTAL TORN-OFF BALLOON PART WAS RETRIEVED AND REMOVED TOGETHER WITH THE 5F SHEATH. NO INJURY TO THE PATIENT WAS REPORTED. THE PATIENT WAS KEPT IN THE CLINIC FOR OBSERVATION FOR AN ADDITIONAL DAY AND WAS DISCHARGED FROM THE HOSPITAL WITHOUT FURTHER CONSEQUENCES.
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Patient 1
OUS MDR - THE RETURNED INSTRUMENT IS TORN IN TRANSVERSAL DIRECTION ABOUT 30 MM PROXIMAL OF THE BALLOON TIP, THE INNER TUBE IS ELONGATED, THE BALLOON IS BUCKLED TOWARDS THE TIP. FURTHER ANALYSIS SHOWS AN ADDITIONAL LONGITUDINAL TEAR IN THE PROXIMAL BALLOON PART (10 MM). AS HAS BEEN REPORTED FROM THE CLINIC, THE AFFECTED BALLOON WAS SUCCESSFULLY INFLATED DURING THE FIRST PASSAGE, THEN RUPTURED SUBSEQUENTLY WHEN MORE PRESSURE WAS ADDED BY A 2-ML OMNIFIX DISPOSABLE SYRINGE. IN A SIMULATION WITH VARIOUS DISPOSABLE SYRINGES OF THE SAME MANUFACTURER (3 ML, 2 ML, AND 1 ML), IT COULD BE SHOWN THAT PRESSURES >20 BAR CAN BE ACHIEVED EFFORTLESSLY. THEREFORE, IT MUST BE ASSUMED THAT THE BALLOON WAS STRESSED BEYOND THE LABELED RATE BURST PRESSURE (RBP) IN THE SEVERELY CALCIFIED STENOSIS. THIS SUSPICION IS BASED ON THE FACT THAT THE PERFORMED DILATATION OF THE BALLOON WAS NOT MONITORED WITH A MANOMETER. IN ADDITION, THE CORRESPONDING PRODUCTION DOCUMENTATION WAS ANALYZED TO RULE OUT THAT THERE MIGHT BE A DEVIATION IN THE PRODUCTION PROCESS AS THE CAUSE. THE PRODUCTION-ACCOMPANYING RECORDS OF THE RESPECTIVE BATCH SHOW NO MANUFACTURING OR QUALITY DEVIATIONS. IN THE CONTEXT OF THE RISK ANALYSIS, WHICH IS PART OF THE CONFORMITY EVALUATION FILE, THE INCIDENT WAS RATED AS REMOTELY IMAGINABLE, WHICH IS EQUIVALENT TO A RATE OF LESS THAN 1 PER 1000. BASED ON THE SALES NUMBERS, A CURRENT RATE OF LESS THAN 0.004% RESULTS FOR THE INCIDENT. IN SUMMARY, THE PRODUCT (BALLOON) WAS DILATED CONTRARY TO THE INSTRUCTIONS FOR USE BY USING A COMMERICAL DISPOSABLE SYRINGE (WITHOUT PRESSURE CONTROL).