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 atlas gold pta dilatation catheter was returned for evaluation.No specific anomalies noted during visual evaluation.In the functional testing the balloon was aspirated prior to inflation, then the balloon was inflated up to 6 atm with in-house presto inflation device, the balloon maintained pressure and shape; no water was leaking.Upon deflation, the balloon took 1mintue and 26 seconds to deflate, which is not within the acceptable range of product specification limit.Further, the balloon was cut and under the microscope it was noted the glue bullet was not seated properly and a kink was noted to the inner guidewire lumen.No other functional testing was performed.Therefore, the investigation was unconfirmed for the reported inflation issue as the balloon inflated without any issue and maintained the shape and pressure during the functional testing.The investigation was confirmed for the reported deflation issue as the balloon took 1 minute and 26 seconds to deflate, which is not within the acceptable range of product specification limits.A definitive root cause for the reported deflation and inflation issue 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: b5, d4 (expiry date: 10/2024), g3, h6(device).H11: section a through f ¿ the information provide 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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