SWAN-GANZ PACING TD CATHETER

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR PRODUCT EVALUATION AS IT WAS DISCARDED. WITHOUT RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. THE DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. AS NO DEVICE WAS RETURNED, A PRODUCT NON-CONFORMANCE OR DEVICE FAILURE COULD NOT BE CONFIRMED AND NO ROOT CAUSE COULD BE DETERMINED. IN THIS CASE, THERE WAS ALSO NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS INDICATE ROOT CAUSE IS NOT LIKELY TO BE RELATED TO THE SWAN-GANZ DEVICE. THE IFU HAS BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. AS PART OF THE MANUFACTURING PROCESS 100% OF THE UNITS GO THROUGH A TIP INSPECTION AND LEAK AND FLOW TEST.

Additional Manufacturer Narrative

THE DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED BY THE FACILITY. HOWEVER, A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE ENGINERING EVALUATION IS COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

Description of Event or Problem

IT WAS REPORTED IN AN ACADEMIC ARTICLE THAT DURING USE OF THE SWAN-GANZ CATHETER THE PATIENT'S TRICUSPID VALVE CHORDAE TENDINEAE RUPTURED. A 55 YEAR OLD MALE UNDERWENT TOTAL ARCH REPLACEMENT FOR STANFORD TYPE B AORTIC DISSECTION. PREOPERATIVELY, CARDIAC FUNCTION WAS PRESERVED AND VALVULAR REGURGITATION WAS TRIVIAL. IMMEDIATELY AFTER SURGERY, CHEST RADIOGRAPHY REVEALED THAT THE PAC WAS KINKED WITHIN THE PULMONARY ARTERY APPROXIMATELY 6 CM FROM THE TIP. THE CATHETER WAS WITHDRAWN UNDER RADIOGRAPHIC MONITORING, BUT THE KINK WAS NOT RESOLVED. IT WAS FURTHER WITHDRAWN TO A DEPTH OF 15 CM WHILE OBSERVING THE PRESSURE WAVEFORM, THEN ADVANCED AGAIN INTO THE PULMONARY ARTERY AFTER BALLOON INFLATION. SUBSEQUENT RADIOGRAPHY CONFIRMED THAT THE KINK HAD BEEN CORRECTED. THE POSTOPERATIVE COURSE WAS INITIALLY UNEVENTFUL HOWEVER, ON POSTOPERATIVE DAY 9, BODY WEIGHT GAIN WAS NOTED, AND ECHOCARDIOGRAPHY REVEALED NEW-ONSET SEVERE TRICUSPID REGURGITATION. ON POSTOPERATIVE DAY 15, TRICUSPID VALVE REPAIR WAS PERFORMED. INITIALLY, PER THE ARTICLE, IT IS HIGHLY LIKELY THAT WHEN THE KINKED PA CATHETER WAS WITHDRAWN INTO THE RIGHT ATRIUM, THE KINKED PORTION BECAME CAUGHT ON THE TRICUSPID VALVE CHORDAE TENDINEAE, RESULTING IN CHORDAL INJIURY. PER INFORMATION RECEIVED FROM A BD APM SALES REP, THE EVENT OF TRICUSPID VALVE CHORDAE TENDINEAE WAS A PROCEDURAL COMPLICATAION AND NOT DUE TO DEVICE MALFUNCTION. THE PATIENT WAS DISCHARGED AFTER THE TRICUSPID VALVULOPLASTY WITHOUT ANY MAJOR ISSUES.