Patient age and weight were requested, but unavailable from the site.Device lot # was requested, but was unavailable from the site as the device was discarded.The expiration date cannot be determined without a lot#.Device manufactured date cannot be determined without the lot#.The device was discarded by the site.There is no allegation that a malfunction of the device caused or contributed to the reported event.
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A philips representative reported that during a coronary laser atherectomy procedure for a chronic total occlusion of the circumflex artery, the physician was unable to advance through the lesion (balloons, etc., would not work).The physician began lasing with the elca coronary laser atherectomy catheter 110-004.An artery was perforated.The physician attempted to stop the bleeding with a balloon, but could not.The patient was transferred to the operating room for repair of the injury.Physician was unsure what caused the artery perforation.The patient's status has been requested from the site, but no information has been provided other than what is contained herein.
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