Continued from concomitant products: cook, ds-60cc-s, dilation syringe; boston scientific alliance inflation handle.Investigation evaluation: an evaluation of the photos provided by the user confirmed the report.In the photos provided, a crack can be seen in the catheter.Without return of the complaint device, an exact measurement of the crack from the distal end of the device could not be determined.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.Damage to the catheter can occur if the device experiences excessive pressure during general handling.Prior to distribution, all hercules 3 stage wireguided balloons esophageal-pyloric-colonic are subjected to a visual examination 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: 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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