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 frayed fibers on the barrel of the balloon.Additionally, a loop of unraveled fibers was noted on the balloon.Therefore, the investigation is confirmed for both frayed and unraveled fibers.Per the reported event details, the device allegedly appeared to have been caught on a stent (wall stent).Therefore, it is likely that an interaction with the stent contributed to the identified fiber issues.However, the definitive root cause for the identified issues could not be identified 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.(expiry date: 09/2021).
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