H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one conquest pta dilatation catheter was returned for evaluation.Unraveling fibers were able to be observed on the balloon; no other anomalies were noted during the visual evaluation.During the functional testing, the balloon was inflated with an in-house presto inflation device, and the balloon was noted to be leaking.Once, after stripping the fiber of the balloon under microscopic observation, a large compound rupture was noted in the balloon.No other functional testing was performed.As the sample analysis confirmed, the unraveling fibers and compound balloon rupture were noted under microscopic observation.Hence, the investigation confirms the reported balloon rupture and the identification of unraveling fibers.A definitive root cause for the reported balloon rupture and the identified unraveling fibers could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G, procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 01/2026).H11: section a through f: the information provided by bd represents all 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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