As the lot number for the device was provided, a device history review was performed.The sample was returned to the manufacturer for inspection/evaluation.Investigation of the received sample confirmed the alleged malfunction.Balloon rupture was noted to be the likely root cause for the inflation issue.However, the definitive root cause for the balloon rupture and peeled pebax could not be determined based on available information.It is unknown whether patient or procedural issues contributed to the event.The device is labeled for single use.
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