It was reported via a call from the material manager/heart center that the event occurred while in the cath lab.During the case the md inserted an ai-07124 via radial and it was found that the catheter leaked; pin holes in the balloon were reported.As a result, the catheter was removed successfully.A new ai-07124 was inserted via the same insertion site and the procedure went on as planned successfully.There was no report of patient death, complications or injury.No medical/surgical intervention was required.There was a slight delay or interruption in therapy while the new kit was opened with no harm to the patient noted.The patient outcome is fine.The material manager stated it is unknown when this event occurred.
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