EP DIAGNOSTIC CATHETER WITH AUTO ID DEFLECTABLE QUADRIPOLAR D CURVE

Additional Manufacturer Narrative

IT WAS REPORTED THAT A FRAIL OLDER FEMALE PATIENT (PATIENT WEIGHT 55KG) WITH A MEDICAL HISTORY OF SUPRAVENTRICULAR TACHYCARDIA (SVT) UNDERWENT AN ELECTROPHYSIOLOGY STUDY PROCEDURE WITH TWO REPROCESSED EP DIAGNOSTIC CATHETERS WITH AUDIO ID DEFLECTABLE QUADRIPOLAR D CURVE AND EXPERIENCED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS. THE PRODUCT WAS RETURNED TO STERILMED FOR EVALUATION ON 6-AUG-2021. STERILMED PERFORMED VISUAL INSPECTION AND AN EVALUATION OF ALL FEATURES OF THE CATHETER. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT DIAGNOSTIC EP CATH WAS RETURNED WITH NO APPARENT DAMAGE. PER THE EVENT, SEVERAL TESTS WERE PERFORMED. AN ELECTRICAL TEST WAS PERFORMED ON THE CATHETER AND IT WAS FOUND WITHIN SPECIFICATIONS. IN ADDITION, THE PRODUCT WAS DEFLECTING CORRECTLY. MAGNETIC SENSOR FUNCTIONALITY WAS TESTED ON CARTO, AND IT WAS PROPERLY RECOGNIZED AND VISUALIZED. NO ERRORS WERE OBSERVED ON SCREEN. AS PART OF STERILMED¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO NON-CONFORMANCES RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS. THE INSTRUCTIONS FOR USE STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

Additional Manufacturer Narrative

THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. CARDIAC TAMPONADE IS A KNOWN POTENTIAL PROCEDURAL COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF A STERILMED REPROCESSED EP DIAGNOSTIC CATHETER WITH AUDIO ID DEFLECTABLE QUADRIPOLAR D CURVE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. BASED ON THE INFORMATION AVAILABLE FOR REVIEW; THE ROOT CAUSE OF THE EVENT CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER PROCEDURAL OR PATIENT FACTORS MAY HAVE CONTRIBUTED. THERE WERE NO ALLEGED ISSUES OR MALFUNCTIONS ASSOCIATED WITH THE REPROCESSED STERILMED DEVICE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURE REPORT NUMBERS 2134070-2021-00013 AND 2134070-2021-00014 ARE RELATED TO THE SAME EVENT. MANUFACTURER'S REF. NO: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A FRAIL OLDER FEMALE PATIENT (PATIENT WEIGHT (B)(6)) WITH A MEDICAL HISTORY OF SUPRAVENTRICULAR TACHYCARDIA (SVT) UNDERWENT AN ELECTROPHYSIOLOGY STUDY PROCEDURE WITH TWO REPROCESSED EP DIAGNOSTIC CATHETERS WITH AUDIO ID DEFLECTABLE QUADRIPOLAR D CURVE AND EXPERIENCED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS. DURING THE STUDY PHASE, THE CATHETERS WERE PLACED, AND ONCE PROPRANOLOL WAS ADMINISTERED, HER HEART RATE INCREASED TO 140 AND THEN HER BLOOD PRESSURE DROPPED. THE DOCTOR COMPLETED AN INTRA-CARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING AND WAS ABLE TO DETECT THE LIQUID. AS A RESULT, THE PATIENT UNDERWENT A PERICARDIOCENTESIS. IT IS UNKNOWN HOW THE PATIENT DEVELOPED AN EFFUSION. THE PATIENT WAS MONITORED IN THE INTENSIVE CARE UNIT DUE TO HAVING A CATHETER IN HER PERICARDIUM. THE OUTCOME OF THE ADVERSE EVENT IS THAT THE PATIENT IS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THE EVENT IS THAT IT WAS RELATED TO PATIENT CONDITION, SINCE THE PATIENT WAS FRAIL AND OLDER. NO ABLATION WAS PERFORMED PRIOR TO DISCOVERING THE CARDIAC TAMPONADE.