Description of Event or Problem · 1
I WOULD LIKE TO REPORT WHAT I BELIEVE TO BE AN INHERENTLY UNSAFE MEDICAL DEVICE. I AM A GENERAL SURGEON IN (B)(6). THIS YEAR LEMAITRE VASCULAR HAS MADE CHANGES TO THE CONSTRUCTION AND PACKAGING OF THEIR REDDICK CHOLANGIOGRAM CATHETERS, PRODUCT NUMBERS 2401-52 AND 2400-53, THAT IN MY OPINION MAKE THE PRODUCTS INHERENTLY UNSAFE. THE CHOLANGIOGRAMS CATHETERS HAVE A BALLOON AT THE END THAT THE SURGEON INFLATES TO HOLD THE CATHETER IN PLACE. THIS YEAR, I HAVE PROBABLY HAD UP TO A DOZEN CATHETER TIPS BREAK OFF WHERE THE TIP CONTAINING THE BALLOON JOINS THE CATHETER. I HAD THREE BREAK OFF AT ONE OPERATION. THE TIPS WOULD BREAK OFF BEFORE THE CATHETERS WERE INSERTED INTO THE PT. IN EACH INSTANCE I HAVE ASKED THE OPERATING ROOM CREW TO RETURN THE CATHETER TO THE COMPANY FOR EXAMINATION. THE PERSON IN THE OPERATING ROOM IN CHARGE OF THAT AREA ESTIMATES THAT THE OPERATING ROOM CREW ACTUALLY GAVE HIM 5 OF THE CATHETERS TO RETURN, BUT THE PRODUCT REP FOR THE COMPANY ONLY CAME TO THE HOSP AND PICKED UP 2 OF THE BROKEN CATHETERS. THE PRODUCT REP ACKNOWLEDGES RECEIVING 2 BROKEN CATHETERS. THE OTHER CATHETERS WERE APPARENTLY DISCARDED. IF A CATHETER TIPS WERE TO BREAK OFF INSIDE A PT, IT WOULD AT LEAST BE AN UNNECESSARY FOREIGN BODY, AND IF IT WERE TO BREAK OFF INSIDE THE PT'S BILE DUCT, IT WOULD BE A MAJOR MEDICAL ISSUE. I HAVE NOT HAD A TIP BREAK OFF IN SEVERAL WEEKS, SO THE MFR MAY HAVE ALREADY ADDRESSED THEIR PRODUCTION PROBLEM, BUT I HAVE RECEIVED NO FEEDBACK FROM THE COMPANY MYSELF. IT IS INHERENTLY UNSAFE TO HAVE THE CATHETER TIPS BREAK OFF. WHEN THE CATHETER IS INSERTED INTO THE PT'S BILE DUCTS FOR INJECTION OF DYE FOR X-RAYS, THE BALLOON IS INFLATED TO HOLD THE CATHETER IN PLACE. THERE IS NO SET VOLUME USED TO INFLATE THE BALLOON BECAUSE EVERY PT'S BILE DUCT IS A DIFFERENT SIZE. THE BALLOON IS INSTEAD INFLATED TO "MINIMUM SEAL" BY FEEL. LEMAITRE PREVIOUSLY PROVIDED A SYRINGE WITH THE CATHETERS THAT GAVE EXCELLENT TACTILE FEEDBACK TO THE SURGEON, BUT THEY HAVE CHANGED TO A DIFFERENT SYRINGE THAT SEEMS TO PROVIDE NO TACTILE FEEDBACK, SO I CAN'T TELL WHETHER THE BALLOON IS INFLATED PROPERLY UNLESS I USE ANOTHER SYRINGE NOT PROVIDED BY LEMAITRE. USING LEMAITRE'S NEW SYRINGE INCREASES THE RISK OF BILE DUCT INJURY. IT IS INHERENTLY UNSAFE TO PROVIDE SYRINGES WITH INADEQUATE TACTILE FEEDBACK. FINALLY, LEMAITRE HAS CHANGED THE PACKAGING OF THE PRODUCTS. THE "PEEL PACK" PACKAGE CONTAINING THE STERILE CATHETER IS NOW INSIDE A SECOND OUTER "PEEL PACK", THE INSIDE OF WHICH IS NOT STERILE. OPERATING ROOM CREWS ARE ACCUSTOMED TO THE INSIDE OF ALL "PEEL PACKS" CONTAINING PRODUCTS MEANT FOR USE IN A STERILE OPERATING ROOM SETTING BEING STERILE ON THE INSIDE. I HAVE ASKED SEVERAL OPERATING ROOM RNS WITH OVER 20 YEARS EXPERIENCE WHETHER THEY HAVE EVER SEEN SUCH A PRODUCT THAT WAS NON-STERILE, AND THEY TOLD ME THEY HAD NOT. LEMAITRE JUST RECENTLY CHANGED THE PRODUCT PACKAGING AND I HAVE ALREADY HAD 2 INSTANCES WHERE THE OPERATING ROOM CREW OPENED THE NON-STERILE PACKAGE ONTO THE STERILE SURGICAL FIELD THINKING THE CONTENTS OF THE OUTER PACKAGE WAS STERILE. THERE MAY HAVE BEEN OTHER INSTANCES WHERE THE PROBLEM WAS NOT CAUGHT BECAUSE EVERYONE IN THE ROOM ASSUMED THE PACKAGING WAS STERILE. SUCH AN OCCURRENCE WOULD CONTAMINATE THE ENTIRE SURGICAL FIELD. EVERY OTHER MFR THAT I KNOW OF WHO WANTS TO PROTECT THEIR PRODUCTS USED IN THE OPERATING ROOM ASSUMES THAT THE INSIDE OF A CARDBOARD BOX IS NON-STERILE, AND EVERYONE IN THE OPERATING ROOM ASSUMES THAT THE INSIDE OF A "PEEL PACK" IS STERILE. LEMAITRE HAS A LABEL ON THE NEW PACKAGE STATING THAT THE INSIDE IS NOT STERILE, BUT THIS IS NOT ADEQUATE. EITHER THE INSIDE OF THE "PEEL PACK" SHOULD BE STERILE, OR THEY SHOULD NOT USE A "PEEL PACK." THE CURRENT PACKAGING IS CONFUSING AND INCREASES THE RISK OF CONTAMINATING THE STERILE SURGICAL FIELD WITH A NON-STERILE ITEM. THAT IS INHERENTLY UNSAFE. I SPOKE WITH THE LEMAITRE PRODUCT REP ABOUT MY CONCERNS OVER TWO WEEKS AGO, AND THE HOSPITAL'S QUALITY DEPARTMENT ALSO CONTACTED THE COMPANY. I HAVE RECEIVED NO FEEDBACK FROM THE COMPANY AS YET. NO PTS HAVE BEEN HARMED, TO MY KNOWLEDGE, BUT THE RISK IS GREAT ENOUGH THAT I BELIEVE THAT THE FDA SHOULD INVESTIGATE AND CONTACT THE COMPANY ABOUT THESE PROBLEMS. DATES OF USE: (B)(6) 2012.