Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report of leakage and determined the intraductal exchange (ide) port was damaged.The stylet wire and the prepackaged syringe were both included in the return of the device.The prepackaged syringe was attached to the inflation port and it was concluded that a pinhole was in the balloon material.The device measured at 202.3 cm from the distal end of the y-juncture hub which meets the specified requirement.The ide port was observed under magnification and was found to have been damaged.The ide port appeared to be slightly twisted.The distance from the distal end of the ide port to the distal end of the tip of the device is 5.4 cm which is within the tolerance.An additional functional verification was performed using the device to simulate an exchange using the ide port.The balloon was advanced through a duodenoscope that was placed in a simulated biliary position.The duodenoscope has an accessory channel that is 4.2 mm in diameter (model number olympus tjf-160v).Using a 0.035" tracer metro wire guide, a wire guide exchange was simulated.During the exchange, the wire guide remained in the simulated biliary duct and access was maintained.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The catheter exhibited damage (twisted, elongation and kinking of the ide port).The damage suggests excessive force was applied to the catheter.The damage to the ide port could contribute to difficulties during an exchange.The instructions for use state: "unlock short wire from wire guide locking device and advance tip of balloon catheter onto prepositioned wire guide ensuring wire guide exits catheter at ide port." the instructions for use state: "advance device in short increments until it is endoscopically visualized exiting endoscope." this activity will aid in device preservation.If the elevator of the endoscope is placed in the closed position with the extraction balloon catheter inside the accessory channel, this can contribute to damage to the catheter.Prior to distribution, all fusion extraction balloon with multiple sizings are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
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