The device history record review confirms that the device met all material, assembly and performance specifications.During attempted inflation of the balloon, a leak was noted at the guidewire port and the balloon would not inflate normally.Magnified examination inside the inflation port revealed that the shaft was perforated, which is likely where the leak was occurring.No other anomalies were noted.Although no leaks were found in the balloon section of the subject device, the reported complaint was confirmed as it is possible the user referred to the inner shaft proximal hub leak as a balloon leak.Based on the examination of the damage inside the inflation lumen (balloon port), it appears that the guidewire was inserted into the balloon port (instead of the guidewire lumen), leading to the observed damage and reported leak.Per the device directions for use (dfu): ¿introduce the guidewire, flexible-end first, into the straight (back) port of the manifold.To avoid kinking, advance the guidewire slowly in small increments to the end of the balloon catheter.¿ additionally, the dfu provides a diagram which shows the balloon port and guidewire port.Previous discussions with manufacturer (boston scientific, (b)(4)), have confirmed that the manufacturing process has associated controls related to manifold leaks for the gateway devices.These include, 100% visual inspection for balloon/shaft integrity, leak and vacuum decay testing (vdt) prior to packaging.Therefore, it is considered unlikely that the damage noted on the returned unit occurred prior to shipment.Review of the reported information, product analysis results, and manufacturing records revealed no evidence of any design or manufacturing specification non-conformances related to the complaint device.Therefore an assignable cause of handling damage has been assigned to this investigation.
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