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 dorado pta dilatation catheter has been received for the evaluation.On the visual evaluation, the device was noted bloody.No other specific anomalies were noted.On the functional evaluation, the balloon was inflated using an in-house presto inflation device and water was noted to be leaking from the distal tip.The device was examined under the microscopic observation and a circumferential break was noted at the glue joint.Then the balloon was cut and noted a hole at the proximal end of the guidewire lumen.No other functional testing performed.Therefore the investigation for the reported leak was confirmed as the water starts leaking from the circumferential break at proximal glue joint of the balloon upon inflation.The investigation for identified break was confirmed as the circumferential break was noted at proximal glue joint of the balloon under the microscopic observation.The investigation for the identified guidewire lumen hole was confirmed as the hole was noted at the inner guidewire lumen at proximal end of the balloon under the microscopic observation.The identified break at proximal glue joint of the balloon and the guidewire lumen hole are likely the root cause for the reported leak.However a definitive root cause for the reported leak and the identified break, guidewire lumen hole 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: 11/2023).
|