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 true dilation pta dilatation catheter has returned for evaluation.On the visual evaluation the device appeared clean.The distal tip was not present on the returned device and the catheter tip appeared blunt.No anomalies were noted to the device.On the functional evaluation the device inflated with in-house presto device and the device maintain shape and pressure, however upon inflation water leaks from the distal end of the balloon.Microscopic observation was performed and noted the break at the balloon distal tip.No further testing performed.Therefore, the investigation for the reported inflation issue has confirmed as the as fluid is leaking out during inflation on the functional evaluation.The investigation has confirmed for the identified leak and break as the water leaks from the distal end of the balloon upon inflating the device.A definitive root cause for the alleged inflation issue and identified leak and 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: 06/2023), g3, h6(device) ; h11: b5,h6(method, result, conclusion) ; 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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