D
Patient 1
THE PT PRESENTED FOR AN ELECTIVE WATER-INDUCED THERMOTHERAPY ("WIT") PROCEDURE ON 12/21/1999 USING THE ARGOMED THERMOFLEX SYSTEM. TO INITIATE THE PROCEDURE, THE (INDWELLING) FOLEY CATHETER WAS REMOVED WITHOUT INCIDENT. A FLEXIBLE CYSTOSCOPY PROCEDURE WAS PERFORMED ON THE PT TO MEASURE THE PROSTATIC URETHRAL LENGTH, WHICH THE PHYSICIAN ESTIMATED TO BE BETWEEN 2.0 AND 2.5 CM. THE UROLOGIST CHOSE TO USE A 2.5 CM WIT PROSTATIC CATHETER, A DISPOSABLE, SINGLE-USE COMPONENT OF THE THERMOFLEX SYSTEM. THE PHYSICIAN WAS UNABLE TO INSERT THE CATHETER INTO THE BLADDER. THE WIT CATHETER WAS REMOVED AND AN ATTEMPT WAS MADE TO REINSERT IT. THE UROLOGIST ASKED THE NURSE FOR A WIRE GUIDE TO ASSIST IN PLACEMENT, HOWEVER THE OFFICE WAS NOT EQUIPPED WITH ONE. UROLOGIST THEN REQUESTED A URETERAL CATHETER, TO USE INSTEAD OF A WIRE GUIDE. THE PHYSICIAN WAS UNABLE TO PLACE THE URETERAL CATHETER INTO THE BLADDER. MD THEN ATTEMPTED TO PLACE A FOLEY CATHETER, WHICH WAS UNSUCCESSFUL. THE PT WAS TRANSFERRED TO ANOTHER ROOM TO UNDERGO A RIGID CYSTOSCOPY. A COUNCILL (OPEN-ENDED) URETHRAL CATHETER WAS PLACED OVER FILIFORMS. SHORTLY AFTER PLACEMENT OF THE COUNCILL CATHETER, PT COMPLAINED OF BEING COLD AND BEGAN TO SHIVER UNCONTROLLABLY. PT WAS FEBRILE WHEN TEMPERATURE WAS TAKEN (RESULTS UNKNOWN). PT'S SPOUSE STATED THAT PT HAD A LOW-FEVER FOR THE PREVIOUS 2 TO 3 DAYS. THIS WAS UNKNOWN AT THE START OF THE WIT PROCEDURE. THE PT DRESSED AND WAS DRIVEN TO THE EMERGENCY DEPARTMENT AT A LOCAL MED CTR BY SPOUSE, WHERE IV ANTIBIOTICS WERE ADMINISTERED. PT WAS ADMITTED AS AN INPATIENT. IN A CONVERSATION WITH THE UROLOGIST ON WED, 12/22/1999, DR STATED THAT PT WAS DOING FINE, AND ATTRIBUTED THE INCIDENT TO THE UNSUCCESSFUL ATTEMPTS AT CATHETER PLACEMENT, AS THE PT'S PROSTATIC URETHRA HAD BEEN PERFORATED. THE THERMOFLEX WIT PROSTATIC CATHETER WAS NEVER SUCCESSFULLY PLACED, NOR WAS THE THERMOFLEX TREATMENT INITIATED. ON THURSDAY, 12/23/1999, THE PT UNDERWENT A TURP WITHOUT INCIDENT. BASED ON INFORMATION PROVIDED, IT APPEARS THAT THIS INCIDENT IS NOT RELATED TO ANY DESIGN CHARACTERISTIC OR ATTRIBUTE OF THE THERMOFLEX WIT PROSTATIC CATHETER. RATHER THE EVENT APPEARS TO BE RELATED TO USE OF THE DEVICE IN A PT WHO MAY HAVE PRESENTED FOR TREATMENT WITH CONTRAINDICATING CONDITIONS, INCLUDING PRIOR CATHETERIZATION INDICATIVE OF URINARY RETENTION, A LOW GRADE FEVER AND/OR PROBABLE URINARY TRACT INFECTION. THE REPEATED URETHRAL TRAUMA RESULTING FROM THE REMOVAL OF THE INDWELLING FOLEY CATHETER, THE TWO (2) CYSTOSCOPIC PROCEDURES, AND THE MULTIPLE ATTEMPTS AT CATHETER PLACEMENT IN COMBINATION WITH THE PROBABLE PRE-EXISTING URINARY TRACT INFECTION PRODUCED TISSUE INFLAMMATION AND SWELLING, THUS MAKING THE PLACEMENT OF THE WIT PROSTATIC CATHETER MORE DIFFICULT, AND CONTRIBUTING TO THE PRESUMED URETHRAL PERFORATION. THIS REPORT HAS BEEN THE ONLY REPORT OF THIS TYPE OF EVENT WITH THE DEVICE.