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.Frayed fiber and fiber disturbance were observed on the returned balloon during the visual evaluation.On the functional testing, the balloon was inflated with an in-house presto inflation device.At inflation, the balloon leaks from the distal end.Further, the balloon fibers are stripped and, under microscopic observations, longitudinal rupture was observed.No other functional testing was performed.Also, one photo review was reviewed.In the photo, the balloon appeared to be bloody and partially inflated in condition.Fiber disturbance was observed in the middle portion of the balloon around its waist, making the balloon appeared to be deformed in middle portion.No objective evidence balloon rupture could can be observed in the submitted photo.As the returned catheter shows the evidence of frayed fiber and fiber disturbance was observed during the visual evaluation and the submitted photo shows the same anomalies of fiber issue and under microscopic observations, a longitudinal balloon rupture was confirmed.Hence, the investigation was confirmed for the reported balloon rupture and identified frayed fiber and fiber disturbance.A definitive root cause for the reported balloon rupture and identified frayed fiber and fiber disturbance could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 05/2026) 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.H3 other text : see h10.
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