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 lutonix 035 drug coated balloon catheter in two segments has returned for evaluation were one of the segments of the catheter was loaded with a unknown guide wire.On the visual evaluation one segment contain detached hub and proximal part of the balloon, the balloon noted to have complete circumferential rupture and detachment balloon material was not returned for evaluation, the second segment contain distal end of the catheter and exposing the inner guide wire lumen, the entire guide wire lumen was noted to be bunched.A clear opaque material was noted at the distal tip of the catheter, dry blood was noted to be inside of the inflation luer.All the anomalies noted on the microscopic observation.No further testing performed due condition of the device.Therefore, the investigation was confirmed for balloon rupture as a compound balloon rupture was noted on the returned device.The investigation was also confirmed for balloon and catheter detachment as the device returned into two segments and detached distal portion of the detached balloon not returned for evaluation.The investigation was also confirmed identified difficult to remove, device-device incompatibility and material separation as the catheter was noted to be loaded with a unknown guide wire and opaque material was noted at the distal tip of the catheter.The opaque material noted during evaluation most likely contributed to the identified device incompatibility and difficult to remove.However, the definitive root cause for the identified device incompatibility, difficult to remove and identified material separation and reported balloon rupture and detachment of device component could not be determined based upon available 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: (expiry date: 07/2023).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.
|