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 rx pta dilatation catheter in two segments has returned for evaluation, however the detachment of catheter was observed to be an incidental finding.On the visual evaluation of the returned device, it consists of two segments in detached potions, a kink was noted right next the detached catheter end.No other anomalies noted.No functional performed due to the condition of the device returned for evaluation.Therefore, the investigation for the reported material deformation was confirmed for, as the catheter was returned for evaluation with a kink.A definitive root cause for the alleged material deformation could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 08/2022).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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