H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one device was returned for evaluation.The device was able to be flushed and inserted with an in-house guidewire without any issues.The balloon was then inflated using an in house presto device to nominal pressure and water was noted to be leaking from the proximal end of the balloon.The balloon fibers were removed and a partial circumferential break was noted to the proximal glue joint.Therefore, the investigation is confirmed for the reported inflation issue, as the device could not be inflated to nominal pressure during evaluation.The investigation is also confirmed for the reported leak and glue joint break as a partial circumferential break was noted to the catheter balloon glue joint break during evaluation.The glue joint break noted during evaluation most likely contributed to the leakage noted.The leakage noted most likely contributed to the reported inflation issue.The definitive root cause for the reported inflation issue and the identified leakage and break could not be determined.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 (expiry date: 07/2023), g3, h6(method) 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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