Model Number H7493941828300 |
Device Problems
Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528); Material Deformation (2976)
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Patient Problem
Non specific EKG/ECG Changes (1817)
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Event Date 12/14/2021 |
Event Type
Injury
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Event Description
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It was reported that difficulty removing a balloon, elevated st changes in an ekg occurred, and failure to deflate a balloon occurred.The target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery (lad).A 3.00 x 28mm synergy xd was advanced, the balloon was inflated for 11 seconds, and the stent deployed in the lesion.It was noted that the balloon was initially slow to inflate.Upon deflation, the proximal end of the balloon would not come down.The indeflator was pulled negative, but the proximal end of the balloon remained inflated, which caused st changes in an ekg.An empty 20cc syringe was then attached to the stopcock, and was pulled negative, which allowed the balloon to deflate enough to remove it.It was noted that 30 seconds were attempted to deflate the balloon, and vacuum was held during withdrawal.After the balloon was removed, the device was inspected for kinks and defects.It was noticed that the hub was bent.It was noted that there were some mild bends in the delivery platform, but no kinks noted prior to removal.It was additionally noted that the balloon was partially inflated, as it did not fully deflate, even with the indeflator attached.The procedure was completed.No further patient complications resulted in relation to this event.
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Event Description
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It was reported that difficulty removing a balloon, elevated st changes in an ekg occurred, and failure to deflate a balloon occurred.The target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery (lad).A 3.00 x 28mm synergy xd was advanced, the balloon was inflated for 11 seconds, and the stent deployed in the lesion.It was noted that the balloon was initially slow to inflate.Upon deflation, the proximal end of the balloon would not come down.The indeflator was pulled negative, but the proximal end of the balloon remained inflated, which caused st changes in an ekg.An empty 20cc syringe was then attached to the stopcock, and was pulled negative, which allowed the balloon to deflate enough to remove it.It was noted that 30 seconds were attempted to deflate the balloon, and vacuum was held during withdrawal.After the balloon was removed, the device was inspected for kinks and defects.It was noticed that the hub was bent.It was noted that there were some mild bends in the delivery platform, but no kinks noted prior to removal.It was additionally noted that the balloon was partially inflated, as it did not fully deflate, even with the indeflator attached.The procedure was completed.No further patient complications resulted in relation to this event.It was further reported that the balloon was able to deflate by pulling back with an empty 20cc syringe.A 6fr guide catheter was used during the procedure.No resistance was noted during the procedure.
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Search Alerts/Recalls
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