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 catheter was returned for evaluation.Frayed fibers were noted on the catheter and no other anomalies were noted during the visual evaluation.On functional testing, the returned catheter was inflated with an in-house presto inflation device and water was noted to be leaking from the proximal end of the balloon.Further, under microscopic observations, a partial circumferential break was noted at the proximal end of the balloon and catheter.No other functional testing was performed.One photo was reviewed.The photo shows the balloon's inflated condition and appearing bloody.Water steaming near the catheter can be observed.However, the source of leak couldn¿t be observed due to the quality of the photo.The submitted photo doesn¿t show any significant evidence for the source of leak.However, during the microscopic observations, a partial circumferential break noted between the proximal joint end of the catheter and the balloon caused the leak during the inflation of the catheter during the functional testing.Frayed fibers were also observed during the visual evaluation.Hence, the investigation confirmed the reported leak and identified partial circumferential break at the catheter and balloon proximal end and identified frayed fibers.During the microscopic observations, a partial circumferential break noted between the proximal joint end of the catheter might lead to the reported leak.However, the definitive root cause for the reported leak, identified break and frayed 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 (expiry date: 05/2024) 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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