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 lutonix 35 catheter was returned for evaluation.On the visual evaluation of the device a proximal circumferential break was noted on the catheter and a kink on the inner guide wire lumen.No evidence of rupture noted on the balloon and no other specific anomalies or damage noted on the catheter.No functional testing performed.Microscopic observation was performed and all the anomalies noted.Therefore, the investigation for the reported balloon rupture remains unconfirmed as no evidence of rupture noted on the returned device.The investigation was confirmed for the identified catheter break as a proximal circumferential break was noted during the microscopic observation on the catheter.A definitive root cause for the reported balloon rupture and identified catheter break could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 11/2022), g3, h6 (device, method).H11: h6 (result, conclusion).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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