Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.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 balloon.The device was inflated during functional testing and water was seen exiting from the balloon.The fibers were removed, and a pinhole rupture and compound rupture were identified.Therefore, the investigation is confirmed for pinhole and compound ruptures, as well as for frayed fibers.The definitive root cause for the ruptures could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.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.H10: g4, h11: h3, h6 (results 1, conclusion 1) 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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