ARGYLE

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) FOR LOT 230090053 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. A PHYSICAL SAMPLE WAS NOT RECEIVED FOR THE INVESTIGATION; HOWEVER, A PICTURE WAS PROVIDED FOR EVALUATION AND THE REPORTED CONDITION WAS OBSERVED. BECAUSE A PHYSICAL SAMPLE WAS NOT RETURNED, A CERTAIN ROOT CAUSE COULD NOT BE DETERMINED. AT THIS TIME, A CORRECTIVE AND PREVENTIVE ACTION IS NOT DEEMED NECESSARY. WE WILL KEEP MONITORING THE PROCESS FOR ANY ADVERSE TRENDS THAT REQUIRE IMMEDIATE ATTENTION. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT WHILE TRYING TO PLACE THE RIGHT-ANGLED CHEST TUBE IN A CORONARY ARTERY BYPASS GRAFT AORTIC VALVE REPLACEMENT, THE TUBE CAME APART. THEY TYPICALLY TUG ON IT TO PULL IT THROUGH THE SKIN, BUT THIS WAS NOT WHERE THEY TUG. THERE WAS NO PATIENT HARM REPORTED.