Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one dorado pta dilatation catheter has been received for the evaluation.On the visual evaluation, the device appeared bloody and no cracks was noted on to the inflation hub.No other specific anomalies were noted.On the functional evaluation, the balloon was inflated using an in-house presto inflation device and the water starts leaking from the distal end of the balloon.Under microscopic examination glue was not fully distributed and not secured to the glue fillet, several holes were noted to the glued area.One video was reviewed.The video shows that the water was leaking from the glue fillet joint and no other anomalies were noted.Therefore, based on the video review, the reported leak can be confirmed as the water leaking from the glue fillet joint.Therefore the investigation for the reported leak can be confirmed as the water starts leaking from the glue fillet joint upon inflation.The investigation for the identified break was also confirmed as the break was noted at the glue fillet joint under the microscopic observation.Although it is likely the identified break on the glue fillet at the hub and the catheter led to the reported leak, a definitive root cause for the reported leak and the identified 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.(expiry date: 06/2023).
|