It was reported that the balloon did not fully deflate.The patient presented experiencing a st-elevation myocardial infarction.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified right coronary artery.A 4.00 x 48 mm synergy xd stent was successfully deployed.The delivery system balloon was then inflated at 15 atm.After many attempts to pull negative pressure for several seconds, the balloon failed to fully deflate and could not be retracted through the guide catheter.The guide catheter, guidewire and partially inflated balloon were pulled and removed as a unit.The procedure was completed successfully with no patient complications reported.
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Device evaluated by mfr.Product analysis: synergy xd mr us 4.00 x 48mm stent delivery system (sds) was returned for analysis.Visual, tactile, microscopic, functional and device-to-device interaction analysis was performed on the device.The device was returned with a guidewire and an nc balloon, all inside the guide catheter.Analysis revealed a break occurring 116.5 cm proximal from the port exchange and multiple kinks along the hypotube shaft.No device issues were found that could have contributed to the break.The manifold was not returned.Severe stretching was found in the midshaft and at the guidewire exchange area of the shaft polymer extrusion profile.The stent was deployed successfully during the procedure and was not attached to the balloon.The balloon cones showed that positive pressure had been applied to the balloon.The balloon was in a deflated state.With the manifold detached the device was attached to an inflation aid.Multiple attempts were made to inflate/deflate the balloon however the inflation liquid could not reach the balloon.The failure to inflate is consistent with the severe stretching along the midshaft.With the two devices inside the guide catheter, resistance was felt when attempting to remove.After soaking in the water bath at 37 degrees, both devices could be removed.
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It was reported that the balloon did not fully deflate.The patient presented experiencing a st-elevation myocardial infarction.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified right coronary artery.A 4.00 x 48 mm synergy xd stent was successfully deployed.The delivery system balloon was then inflated at 15 atm.After many attempts to pull negative pressure for several seconds, the balloon failed to fully deflate and could not be retracted through the guide catheter.The guide catheter, guidewire and partially inflated balloon were pulled and removed as a unit.The procedure was completed successfully with no patient complications reported.
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