DS BREAST ADAPTIVE 16CH MR COIL - DSTREAM

Description of Event or Problem

THE DESIGN OF THE PHILIPS 16 CHANNEL ADAPTIVE COIL IS COMPLETELY UNACCEPTABLE FOR PURPOSES OF BIOPSY. WE ARE ONE OF FEW SITES IN THE COUNTRY WITH DEVELOPING BREAST IMAGING AND BIOPSY PROGRAMS UTILIZING PHILIPS MRI SYSTEMS WITH INVIVO BREAST IMAGING COILS AND ANOTHER BIOPSY SYSTEMS. WE HAVE WORKED WITH APPLICATIONS FOR LONG EXTENDED PERIODS OF TIME FROM EACH COMPANY AND HAVE COME TO A DETERMINATION THAT THE PHILIPS/INVIVO 16 CHANNEL ADAPTIVE COIL THAT IS MARKETED AND WAS SOLD TO US AS A COMBO DIAGNOSTIC IMAGING/BIOPSY COIL THAT WOULD SUIT 100% OF OUR NEEDS IS FALSE. THE DIAGNOSTIC IMAGING PORTION IS ACCEPTABLE, BUT FOR BIOPSY IT IS VERY BELOW THE STANDARD FOR PATIENT CARE. THE MANUAL AND SOFTWARE CALCULATIONS FOR THE BIOPSY TARGETING ARE SO OFF THAT AT LEAST 4 OF 5 ATTEMPTS INTO A PHANTOM THE BIOPSY MASS WAS MISSED COMPLETELY. WE HAVE REFUSED TO USE THE COIL AND BIOPSY SYSTEM ON ACTUAL PATIENTS. THE 16 CHANNEL COIL IS THE PROBLEM AND IS NOT DESIGNED OR ADAPTED FOR SUCCESSFUL BIOPSY LIKE IT'S MARKETED AND SOLD. WE MET WITH PHILIPS AND THEY SAID IN EUROPE IT'S BEEN PULLED FROM THE MARKET AND THE SALES REP TOLD US HE WON'T SELL THE COIL TO CUSTOMERS ANYMORE. MANUFACTURER RESPONSE FOR COIL, MAGNETIC RESONANCE, SPECIALTY (BREAST), DS BREAST ADAPTIVE 16CH MR COIL (PER SITE REPORTER). THE MANUFACTURER ACKNOWLEDGED THE ISSUE, STATED THAT THEY FULLY UNDERSTAND OUR POSITION AND THAT ADDITIONAL APPLICATIONS TRAINING WOULD NOT SOLVE THE ISSUE; HOWEVER, REFUSED RETURN OF THE COIL, BUT OFFERED QUOTE FOR A DIFFERENT PRODUCT.