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 ultraverse 035 pta dilatation catheter was returned for evaluation.No specific anomalies were noted during the visual evaluation.During the functional testing, the balloon was successfully inflated using the in-house presto inflation device.However, under microscopic observation, a pinhole rupture was noted on the balloon.Although during the functional testing the balloon inflated successfully, water was leaking from the balloon; therefore, investigation for the reported inflation issue was confirmed as water was also noted to be leaking from the pin-hole balloon during inflation.The investigation was also confirmed for the identified balloon rupture, as during the inflation of the device, a pinhole rupture was noted, which was also confirmed under microscopic observation.A definitive root cause for the reported inflation issue and identified pin-hole balloon rupture could not be determined based upon the provided information.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H10: d4 (expiry date: 03/2024).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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