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 catheter was returned for evaluation.Distal tip of the balloon was noted to be inflated abnormally and the balloon was inflated with an unknown fluid.Unraveled fiber was also observed on the returned balloon.No other anomalies were noted during the visual evaluation.On functional testing, the balloon was deflated and again re-inflated to 6 atm and the balloon was still observed to be inflated in an abnormal condition.No other functional testing.One photo was reviewed.The photo shows the balloon in an inflated condition and the distal end of the balloon is bulged.The photo showed the balloon was not inflated uniformly along the length of the balloon.No other anomalies noted.As the submitted photo and returned sample analysis confirms the evidence of abnormal inflation and the balloon was noted to be bulged near the distal end of the balloon, the investigation is confirmed for the reported abnormal inflation.The investigation is also confirmed for the identified unraveled balloon fiber material as it was observed on the returned balloon material.A definitive root cause for the reported abnormal inflation and identified unraveled balloon fiber could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 03/2026) h11: section a through f ¿ the information provided 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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