H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: one conquest 40 pta catheter was retuned for evaluation.On the visual evaluation of the device, the balloon appeared bloody and peeled pebax was noted on the balloon from the distal end.No other anomalies noted.On the functional evaluation of the device, the balloon was attempted to inflate with in-house presto device, but it was unsuccessful.Then the balloon was cut at the proximal for further observation and it was noted end dried contrast solution and the inflation port found to be collapsed.Microscopic observation also performed and confirms the same.No further testing performed due to the condition of the device.Therefore, the investigation is confirmed for the reported inflation issue as the balloon was not able to inflated using the in house presto during evaluation.The investigation is also confirmed for the identified peeled pebax as it was noted on the balloon which returned for evaluation.The collapsed inflation ports noted under magnification, most likely contributed to the reported inflation issue.However the definitive root cause for the alleged inflation issue and identified peeled pebax 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.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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