Device evaluated by mfr.: returned device consisted of a sterling otw balloon catheter.The balloon was loosely folded and there was fluid/contrast in the balloon and inflation lumen, bloody was on the device.The device was soaked in a warm water bath for 6 days.The tip, balloon, markerband, and inner/outer shaft were microscopically, tactile and visually inspected.Inspection revealed a perforation in the inner shaft (located 14 mm distal of the proximal markerband) and numerous kinks in the inner shaft.The inner diameter (id) of the wire lumen was measured at both ends and was within specification.The material of the inner shaft is flared outward, suggesting that the puncture originated from the inside of the inner towards the outside of the device.The wire used in the procedure was not returned with the sterling device, so a lab supplied.018¿ wire was used for functional testing.The wire was back loaded onto the tip of the device, and advanced roughly 22mm, then stopped.The wire could not advance past the area where the inner shaft was punctured.Inspection of the remainder of the device revealed no other damage or irregularities.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
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