It was reported that the urethral catheter was being used to maintain tracheostomy stoma patency.Reportedly, the device became lodged in the patient's left bronchus and an unidentified procedure was required to remove the urethral catheter.After multiple good-faith attempts, the facility contact was unable or unwilling to provide additional patient, product, or procedural information related to this incident.It was not identified how long the urethral catheter was in use for.It was not identified how the urethral catheter was secured to the tracheostomy stoma.No additional information related to this incident was reported to the manufacturer.No sample was returned to the manufacturer for evaluation.The reported use of the urethral catheter to maintain tracheostomy stoma patency is off-label use.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
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