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 and no other visual anomalies were noted.On the functional evaluation, the balloon was inflated to 8 atm using an in-house presto inflation device.Further, the balloon maintained pressure and no water was noted to be leaking from the glue joint.The balloon was then inflated to 24atm again the balloon maintained pressure but water was noted to be leaking at the proximal balloon joint.Under the microscopic observation, the circumferential break was noted at the proximal balloon joint.No other functional testing was performed.Therefore the investigation for the reported inflation issue and leakage was confirmed, as the water was noted leaking at the proximal balloon joint during the functional testing.The investigation for the identified balloon joint break was also confirmed, as the circumferential break was noted at the proximal balloon joint under the microscopic observation.The identified balloon joint break is likely the root cause for the reported inflation issue and leakage.However, the definitive root cause for the reported inflation issue, leakage and the identified balloon joint 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: 02/2024).
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