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 conquest pta dilatation catheter was received for evaluation.During visual evaluation, the sample appeared to have residue throughout.Unraveling of fibers and bunching was noted near the proximal end of the balloon.During functional evaluation, an in-house presto inflation device was used to inflate the balloon and water was noted streaming from the proximal end of the balloon.The balloon fibers were stripped and under microscopic examination, a pinhole rupture was noted to the balloon.No other functional testing performed.Therefore, the investigation is confirmed for the reported balloon rupture as a pinhole balloon rupture was noted to the balloon under microscopic examination.The investigation is also confirmed for the identified unraveled material as unraveling of fibers was noted on the balloon.A definitive root cause for the reported balloon rupture and identified unraveled material 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: 10/2025) h11: section a through f - the information provided by bd represents all of 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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