OUS MDR - THE AFFECTED BALLOON CATHETER WAS USED TO DILATE A SEVERE CALCIFIED 80% STENOSIS IN THE DISTAL ILLIACA COMMUNIS, DIRECTION EXTERNA, WITH A VESSEL DIAMETER OF 7 MM AND A MODERATE BENDED VESSEL ANATOMY. DURING INFLATION THE BALLOON RUPTURED AT A PRESSURE OF 14 BAR (RBP 12 BAR). AFTERWARDS IT WAS NOT POSSIBLE TO WITHDRAW THE RUPTURED BALLOON INTO THE INTRODUCER AND APPROXIMATELY 2 CM OF THE DISTAL PORTION OF THE BALLOON AND INNER SHAFT FRACTURED AND STAYED IN THE PATIENT. THE FRACTURED APPROXIMATELY 2 CM OF THE BALLOON AND INNER SHAFT STAYED IN THE PATIENT AND WERE FIXED TO THE VESSEL WALL BY PLACING A STENT. THERE ARE NO ADVERSE PATIENT EFFECTS REPORTED FOR THIS PATIENT.
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Patient 1
OUS MDR - THE AFFECTED BALLOON CATHETER WAS USED TO DILATE A SEVERE CALCIFIED 80% STENOSIS IN THE DISTAL ARTERIA ILIACA COMMUNIS, DIRECTION EXTERNA, WITH A VESSEL DIAMETER OF 7 MM AND A MODERATE ANGULATED VESSEL ANATOMY. DURING INFLATION THE BALLOON RUPTURED AT A PRESSURE OF 14 BAR (RBP 12 BAR). THE INVESTIGATION OF THE AFFECTED INSTRUMENT REVEALED ABOUT 10 MM DISTAL TO THE PROXIMAL BALLOON CONUS A LONGITUDINAL TEAR OF ABOUT 4 MM AND A RADIAL TEAR IN A DISTAL DISTANCE OF 25 MM TO THE PROXIMAL BALLOON MARKER. THE REVIEW OF THE MANUFACTURING AND LOT HISTORY OF THIS PRODUCT SHOWED THAT THE DEVICE IN QUESTION WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS AND SUCCESSFULLY PASSED ALL IN-PROCESS CONTROLS, INCLUDING THE BURST TEST VALUES, AS WELL AS THE FINAL INSPECTION. BASED ON THE CONDUCTED INVESTIGATION AND THE PROVIDED INFORMATION WE COME TO THE CONCLUSION THAT THE BALLOON WAS MOST PROBABLY PERFORATED IN LONGITUDINAL DIRECTION, DUE TO PRESSURE OVER LOAD ABOVE RATED BURST PRESSURE (14 INSTEAD OF 12BAR) IN THE VERY TIGHT LESION, FOLLOWED BY A TRANSVERSAL TEAR CAUSED DURING THE ATTEMPT TO WITHDRAW THE INSTRUMENT.