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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.A visual inspection found the balloon to be fully detached and was not returned.Additionally, the inner guidewire lumen was stretched distally, indicating retraction issues.Therefore, the investigation is confirmed for balloon detachment as well as for retraction issues.The investigation is also confirmed for a dislodged marker band.The marker band likely dislodged as the inner lumen stretched and as the balloon detached distally.It is likely that the balloon detachment resulted in the retraction issues through the sheath.However, the definitive root cause for the identified balloon detachment 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.(2923 - device code + descrption3).
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