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 returned for evaluation.On the visual evaluation of the device, no other specific anomalies noted.On the functional evaluation of the device, the device was inflated with in-house presto device at 8 atm no leaks noted on the balloon or the catheter.On further the balloon inflated to 22 atm water leaking from the balloon catheter bond joint.Microscopic observation was performed and noted a circumferential break at the proximal glue joint.Therefore, the investigation has confirmed for the reported leak as the water leaks from the catheter during the functional testing.The investigation also confirmed for the identified break as a circumferential break at the proximal glue joint during the microscopic observation of the returned device for evaluation.During the microscopic observation a break was noted on the proximal glue joint on the catheter might contribute the reported leak.However, the definitive root cause for the reported leak and 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: 03/2024).
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