H10: 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 conquest pta dilatation catheter was received for evaluation.During visual analysis, fiber disturbance and material frayed was observed to the distal end of balloon.No other anomalies were noted.On functional testing, an in-house presto inflation device was used to inflate the balloon and water was noted to be leaking from the distal tip of the balloon.Further, the balloon fibers where stripped and under microscopic examination, a longitudinal rupture was noted to the balloon.No other functional testing performed.One photo was provided and reviewed.The photo shows a balloon catheter connected with an inflation device where blood residues noted on the balloon and table.A balloon rupture could not be observed due to the condition of photo.No other anomalies were identified.One video was provided and reviewed.In the video, an unknown inflation device is noted to be connected with the inflation luer of the catheter, but the balloon is not visible in the video.So, the evidence of balloon rupture could not be observed.No other anomalies were identified.Hence, no significant evidence of balloon rupture could be observed from the submitted photo and video.Based on the submitted photo and video, there is no significant evidence of balloon rupture but a longitudinal rupture was noted on the balloon under microscopic evaluation in the functional testing.Further, on visual analysis of returned catheter, fiber disturbance and material frayed could be observed.Therefore, the investigation is confirmed for the reported balloon rupture and identified fiber disturbance & material frayed.A definitive root cause for the reported balloon rupture and identified fiber disturbence, material frayed issues 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: 09/2025) 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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