H10: manufacturing review: a lot history review was conducted and it was determined that a device history record review was not required.Investigation summary: the device was returned for evaluation.A visual inspection found peeled pebax and frayed fibers on the outside of the balloon.An attempt was made to inflate the balloon, however a compound rupture was noted on the balloon.Therefore, the investigation is confirmed for peeling pebax, frayed fibers, and for a compound rupture.However, the investigation is inconclusive for the reported deflation issue as the balloon was unable to be inflated to functionally test for the deflation issue.It is possible that the identified balloon rupture could have contributed to the reported deflation issue and identified frayed fibers and pebax peeling.However, the definitive root cause for the identified failures cold not be determined based on the available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4(expiry date: 08/2022),.
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