Visual analysis of the returned nephromax balloon catheter revealed that the catheter shaft no kinks or damage.A longitudinal tear was identified in the balloon.The tear from the distal markerband extended proximally along the balloon material for a total length of 14mm.A microscopic examination of the balloon material identified no issues which could potentially have contributed to the pinhole leak.Therefore, the complaint was confirmed.The noted damages indicate difficulty was experienced during the procedure and are likely due to anatomical or procedural factors such as tortuous anatomy or maneuvering of the device.Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context.
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It was reported to boston scientific corporation that a nephromax balloon catheter kit was used during a renal lithotripsy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the balloon was inflated at 18atm and contrast was leaking at the distal portion of the balloon as seen in the ct monitor.Reportedly, the balloon did not rupture and the procedure was completed with another nephromax balloon catheter.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be good.
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