Description of Event or Problem · 1
THE PT WAS SCHEDULED FOR A RADIOFREQUENCY ABLATION-FRA-OF A RENAL NEOPLASM. BIOPSY COAXIAL NEEDLE HAD BEEN PLACED AND BIOPSY OF THE RENAL MASS HAD BEEN PERFORMED THROUGH THE COAXIAL NEEDLE. THE COAXIAL NEEDLE IS SPECIALLY DESIGNED BY ANGIODYNAMICS FOR INTRODUCTION OF THE RFA PROBE DEVICE INTO THE AREA THAT NEEDS ABLATION. THE CO-AXIAL NEEDLE IS INSULATED SO AS NOT TO CONDUCT HEAT FROM THE RFA PROBE TO THE AREA SURROUNDING THE NEEDLE. THE COAXIAL NEEDLE IS ANGIODYNAMICS MODEL #700-102331-11CM. AFTER BIOPSY, AN ATTEMPT TO PASS THE RFA PROBE DEVICE, ANGIODYNAMICS XL SEMI-FLEX #700-102615, LOT 938762-31207-THROUGH THE COAXIAL NEEDLE WAS UNSUCCESSFUL AS THE PROBE WOULD GET STUCK AT THE TRANSITION POINT BETWEEN COVERED AND NON-COVERED PORTIONS OF THE PROBE. AT THIS TRANSITION POINT THERE WAS A SMOOTH BUT PALPABLE INCREASE IN THE PROBE DIAMETER. THE ANGIODYNAMICS REPRESENTATIVE WAS IN ATTENDANCE AT THE PROCEDURE AND HE HAD ADDITIONAL DEVICES FOR EVALUATION. A SECOND INTRODUCER NEEDLE WAS OPENED ONTO THE STERILE FIELD #700-102330 - LOT B1QQ AND A SECOND SEMI-FLEX PROBE WAS ALSO OPENED UP ONTO THE STERILE FIELD. NEITHER PROBE WOULD PASS THROUGH EITHER INTRODUCER NEEDLE. BOTH PROBES DEMONSTRATED IDENTICAL SMALL DIAMETER CHANGES AT THE COVERED/NON-COVERED TRANSITION POINT. THE ANGIODYNAMICS REPRESENTATIVE DESCRIBED BOTH PROBES AS HAVING BEEN NEWLY PRODUCED IN THE SAME LOT, PERHAPS ACCOUNTING FOR THE SIMILAR DIFFICULTIES ENCOUNTERED. THE PROCEDURE WOULD HAVE HAD TO BE ABORTED AT THIS POINT, WITH THE PT UNDER HEAVY CONSCIOUS SEDATION, IF NOT FOR THE AVAILABILITY AT OUR FACILITY OF A DIFFERENT RFA PROBE MADE BY BOSTON SCIENTIFIC. WE WERE ABLE TO PLACE THE BOSTON SCIENTIFIC INTRODUCER NEEDLE AND PROBE THROUGH THE ANGIODYNAMICS INTRODUCER NEEDLE AND PROCEED WITH THE CASE IN THAT MANNER. THE PT SUSTAINED NO ADVERSE EVENT, BUT IF NOT FOR THE AVAILABILITY AND COMPATABILITY OF THE BOSTON SCIENTIFIC PROBE THE RFA PROCEDURE WOULD HAVE BEEN ABORTED AND THE PT WOULD HAVE HAD TO UNDERGO UNNECESSARY ADDITIONAL RISK AND ANESTHESIA AT A LATER DATE FOR A REPEAT RFA PROCEDURE. DOSE OR AMOUNT: PROBE, FREQUENCY: SINGLE USE. DATES OF USE ONE DAYS IN 2007. DIAGNOSIS OR REASON FOR USE: HEAT ABLATION OF RENAL NEOPLASM.