The reported issue was unconfirmed.The device was returned and visually inspected.Evaluation found no leakage when pressure was applied on the sac.The sample undergone a 7 day leak test and no leakage was observed.There was no leakage from the valve.The catheter was dissected and no conditions were found that could have contributed to the reported event.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿1.Method for use: (1)do not reuse.(2)do not resterilize.(3)be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (4)do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.]".
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