SCANLAN® MULTI-PURPOSE CLAMP

Additional Manufacturer Narrative

THE INSTRUMENT IN QUESTION WAS NOT RETURNED FOR FURTHER ANALYSIS, AND NO FURTHER INFORMATION WAS MADE AVAILABLE BY THE REPORTING INSTITUTION. REVIEW OF THE DESIGN, MANUFACTURING BATCH RECORD, AND TECHNICAL DOCUMENTATION SHOW THAT THERE WERE NO NON-CONFORMITIES, NO HISTORY OF REPORTABLE EVENTS, AND NO RELEVANT COMPLAINTS. NO ROOT CAUSE CAN BE IDENTIFIED FOR THIS OCCURRENCE FROM THE INFORMATION AVAILABLE. THIS REPORTED OCCURRENCE APPEARS TO BE AN ANOMALY.

Description of Event or Problem

DURING A CARDIOVASCULAR SURGERY (ASCENDING AORTA SURGERY AND AORTIC VALVE PLASTY), THE AORTIC CLAMP BROKE AT THE LEVEL OF ONE OF THE TWO JAWS, CAUSING AN UNEXPECTED REPERFUSION OF A VASCULAR SECTOR CONTAINING AIR AND THUS THREATENING THE PATIENTS VITAL PROGNOSIS. UNFORTUNATELY, THE PATIENT DIED.