Description of Event or Problem · 1
A PARTIAL BREAST IRRADIATION PATIENT WAS TO BE TREATED AT OUR HOSPITAL WITH HIGH DOSE RATE BRACHYTHERAPY. THE DEVICE IMPLANTED INTO THE PATIENT TO ALLOW RECEIPT OF THE HIGH DOSE RATE SOURCE WAS A CONTURA BALLOON MANUFACTURED BY SENORX. THE DEVICE CONSISTS OF 2 WATER PORTS TO ALLOW INFLATION OF THE BALLOON WITH LIQUID AND ONE TO SUCK SEROMA OUT OF THE LUMPECTOMY CAVITY. IT ALSO CONTAINS 5 RADIATION RECEIPT PORTS -OR CATHETERS- THAT ARE SEPARATE FROM THE WATER PORTS AND MUST REMAIN CLEAN IN REGARD TO PATIENT TISSUE. THE PATIENT IS CT SCANNED PRIOR TO TREATMENT. AT THIS TIME, THE PHYSICIST NOTICED THAT THE BLOOD WAS IN THE RADIATION RECEIPT PORTS. THIS IS ODD BECAUSE IF THIS PATIENT WERE TREATED WITH OUR RADIATION SOURCE, IT WOULD CONTAMINATE OUR TREATMENT MACHINE AND CAUSE THOUSANDS OF DOLLARS WORTH OF DAMAGE. ADDITIONALLY, THE INTEGRITY OF THE BALLOON ITSELF IS QUESTIONED DUE TO THE PRESENCE OF THE BLOOD, WHICH COULD RESULT IN A MISADMINISTRATION OF DOSE. THE PHYSICIST INFORMED THE PHYSICIAN AND THE SENORX REPRESENTATIVE WHO HAPPENED TO BE PRESENT. THE SENORX REPRESENTATIVE, MADE SOME PHONE CALLS INQUIRING ABOUT THE BLOOD PRESENT IN THE CATHETERS. AFTER A FEW MINUTES HE REPORTED BACK THAT IT WAS A "KNOWN MANUFACTURING DEFECT" IN CONTURA BALLOONS OVER 6 WEEKS OLD. HE TOLD THE PHYSICIST THAT IT INVOLVED HOW THE 2 WATER PORTS WERE MILLED AND THAT OCCASIONALLY THE MILLING PUNCTURED THE RADIATION CATHETERS CREATING A SYSTEM THAT WAS NO LONGER SEALED. THE REP REPORTED THAT HE WAS TOLD THIS OCCURRED IN 2 OUT OF 1000 CASES. BECAUSE THIS DEVICE IS SURGICALLY IMPLANTED IN THE PATIENT, THE PATIENT WILL HAVE TO GO BACK TO THE SURGICAL SUITE TO HAVE A NEW DEVICE IMPLANTED, DELAYING THE PATIENT'S TREATMENT AND CAUSING THE SURGICAL SUITE TO HAVE A NEW DEVICE IMPLANTED, DELAYING THE PATIENT'S TREATMENT AND CAUSING HER UNDUE STRESS AND DISCOMFORT. THIS HOSPITAL, INCLUDING THE LEAD PHYSICIST AND PHYSICIAN INVOLVED IN THESE CASES, HAVE NEVER BEEN INFORMED OF SUCH A DEFECT IN THE MANUFACTURING OF THE CONTURA BALLOON. ADDITIONALLY, THE FIELD REPRESENTATIVE HIMSELF SEEMED UNAWARE OF SUCH A DEFECT EXISTING. TWO OUT OF 1000 CASES IS SIGNIFICANT IN THAT IF THIS GOES UNDETECTED, IT CAN POSSIBLY CROSS CONTAMINATE BODILY TISSUES BETWEEN PATIENTS, NOT TO MENTION DESTROY OUR HIGH DOSE RATE DELIVERY SYSTEM CAUSING A HUGE AMONT OF MONEY WORTH OF DAMAGE. DATES OF USE 2008. DIAGNOSIS OF REASON FOR USE: BREAST CANCER. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.