Device evaluated by mfr: returned product consisted of a coyote balloon catheter.The balloon was loosely folded and there was contrast and blood in the balloon and lumen.Functional testing was performed by connecting an inflation device filled with water to the hub.When pressure was applied, water was found to be leaking from the balloon.Microscopic examination found a longitudinal burst in the balloon material, starting at the middle of the proximal markerband, and 10mm long distal of the proximal markerband.Microscopic inspection of the markerband found no irregularities or defects.Microscopic inspection found no irregularities or defects.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
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