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 received for evaluation.During visual analysis, balloon fiber unraveling, fiber disturbance, materiel frayed and peel pebax could be noted in the balloon.No other anomalies were noted.During functional testing, an in-house inflation device was used to inflate the balloon and water was noted streaming from the distal end of the balloon.Further the balloon fibers were stripped and under microscopic examination a longitudinal rupture was noted to the balloon.No other functional testing performed.However, only limited information has been reported, based on the return sample analysis balloon fiber unraveled, fiber disturbance, materiel frayed, peel pebax and longitudinal balloon rupture could be identified.Therefore, the investigation was confirmed for the identified material unraveled, fiber disturbance, materiel frayed, peel pebax and longitudinal balloon rupture.A definitive root cause for the identified balloon fiber unraveled, fiber disturbance, peel pebax, materiel frayed, and longitudinal balloon rupture issue 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: 02/2026).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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