H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one dorado pta device has returned evaluation.On the visual evaluation of the device, it appeared bloody.No other anomalies noted.On the functional evaluation of the device, using an in-house presto inflation the device inflated and water leak has noted glue joint.Under microscopic observation circumferential break at the proximal glue joint.Therefore, reported leak and identified break has confirmed as the water leaks from the glue joint on inflating the balloon.It is likely the identified break at the glue joint led to the alleged leak.A definitive root cause for the leak and identified break could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 11/2022).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.H3 other text : see h10.
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