Device Problem
Detachment of Device or Device Component (2907)
Patient Problem
Device Embedded In Tissue or Plaque (3165)
Event Type
malfunction
Manufacturer Narrative
The age of the patient is not known.The lot history record review could be performed as lot number for the subject device was unavailable.
Event Description
Acclarent was informed on 10/30/2015, of an event that occurred on an unknown date involving an unknown type of acclarent balloon.The reported event was that the balloon did not deflate.The physician advised that he needed forceps to manually excise the balloon from the patient.