A complete manufacturing review could not be conducted, as the lot number was not reported for this device.The device was returned for evaluation.A visual inspection found frayed fibers on the balloon.The balloon was inflated with an in-house inflation device and a pinhole rupture was noted on the balloon.Therefore, the investigation is confirmed for frayed fibers and for a pinhole rupture.The definitive root cause for the identified frayed material or pinhole rupture could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(b)(4).
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