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 gold pta dilatation catheter was received for evaluation.Residue was noted throughout.Bunching was noted to the proximal end of the balloon.Fiber disturbance and fraying were observed throughout the balloon.An in-house presto inflation device was used to inflate the balloon, and two pinhole ruptures were noted on the balloon.No other functional testing was performed.One photo was provided and reviewed.The photo shows the atlas gold catheter with the balloon partially deflated.No specific anomalies can be seen.Therefore, the investigation is confirmed for the reported balloon rupture as two pinhole ruptures were noted on the balloon during inflation.The investigation is also confirmed for the identified frayed fibers as fraying of fibers was observed throughout the balloon.A definitive root cause for the reported balloon rupture and identified frayed fibers 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: 10/2025) 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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