Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was returned for evaluation.A visual inspection found a peeled outer layer on the distal cone of the balloon.An inflation attempt was made and a pinhole rupture was noted on the distal cone at the location of the peeling outer layer.Therefore, the investigation is confirmed for a pinhole rupture and peeled outer layer.It is likely that the rupture contributed to the peeling outer layer.However, the definitive root cause for the identified issues could 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.
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