H10: 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 frayed fibers and a peeled outer layer on the surface of the balloon.Therefore, the investigation is confirmed for frayed fibers and peeled outer layer.Additionally, the balloon was inflated with water and a compound rupture was identified on the proximal cone of the balloon, confirming the investigation for the reported rupture.The definitive root cause for the identified defects could not be determined based upon the available information.However, an investigation is currently open to address the peeling outer layer issue.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.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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