MARQUIS® STOPCOCK

Description of Event or Problem

THE ACCOUNT ALLEGES THAT DURING A CATH LAB PROCEDURE, TWO STOPCOCKS HAD TO BE USED DUE TO CRACKING WHEN BEING TIGHTENED ONTO THE MANIFOLD. THEY STATED THERE WAS NO EXCESSIVE FORCE OR PRESSURE APPLIED PRIOR TO THE DEVICE CRACKING. THESE TWO STOPCOCKS WERE DISPOSED OF. A THIRD STOPCOCK WAS APPLIED WITHOUT ISSUE. AFTER THE CATH LAB PROCEDURE THE PATIENT WAS TRANSFERRED TO THE ICU PER NORMAL HOSPITAL PROTOCOL. SEVERAL HOURS LATER, THE PATIENT'S ART LINE BLOOD PRESSURE READING DROPPED. THE NURSE ENTERED THE ROOM AND NOTICED BLOOD ON THE FLOOR AND BEDSHEETS. THE NURSE PULLED BACK THE TOP SHEET AND NOTED BLOOD "SPURTING" FROM THE STOPCOCK. THE NURSE NOTED A VISIBLE CRACK IN THE STOPCOCK WHERE THE BLOOD WAS LEAKING. IT WAS REPORTED THE STOPCOCK FUNCTIONED WITHOUT ISSUE FOR SEVERAL HOURS PRIOR TO THE BLOOD LEAKAGE EVENT. THE PATIENT LATER EXPIRED DUE TO THEIR CO-MORBID CONDITIONS. THE ICU NURSE MANAGER REPORTS THE BLOOD LOSS WAS NOT THE DIRECT CAUSE OF DEATH FOR THE PATIENT BUT THAT IT "DIDN'T HELP".

Additional Manufacturer Narrative

THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Additional Manufacturer Narrative

THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE ESTABLISHED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.