Manufacturing review: a manufacturing review was conducted and 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 the balloon to be inverted and completely detached from the catheter shaft.Therefore, the investigation is confirmed for the reported balloon detachment.The definitive root cause for the reported balloon detachment could not be determined based upon 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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