Description of Event or Problem · 0
[REDACTED NAME] HAS HAD AN INCREASE IN EVENTS WITH THIS SPECIFIC PRODUCT. BIOSENSE WEBSTER HAD TOLD OUR CLINICAL SITE THEY ARE LOOKING INTO IT, BUT THEY DO NOT HAVE ANY FEEDBACK YET. [REDACTED NAME] INTERNAL TRACKER HAS 74 REPORTS TOTAL ON THESE DEVICES SINCE 2021: 38 REPORTS IN THE PAST 12 MONTHS, 10 IN THE LAST MONTH. EVENT #1 [REDACTED DATE]: INVALID CATHETER TEMPERATURE FROM THE ABLATION CATHETER. THE CATHETER WAS REMOVED AND REPLACED WITH NO PATIENT HARM. LOT 31314722L. EVENT #2 [REDACTED NAME]: THE D CURVE OF THE ABLATION CATHETER FAILED TO WORK. THE CATHETER WAS REMOVED AND REPLACED WITH NO PATIENT HARM. LOT 31283830L. EVENT #3 [REDACTED NAME]: THE ABLATION CATHETER DIDN'T FULLY DEFLECT THE D CURVE. THE CATHETER WAS REMOVED AND REPLACED WITH NO HARM TO THE PATIENT. LOT 31296899L. EVENT #4 [REDACTED NAME]: AFTER PLACED INTO THE PATIENT, THE ABLATION CATHETER IMAGE FLIPPED FROM RIGHT TO LEFT ON THE CARTO CONSOLE (MIRROR EFFECT). THE CATHETER WAS REMOVED AND REPLACED WITH NO HARM TO THE PATIENT. THE CATHETER HAS BEEN SENT BACK TO THE MANUFACTURER UNDER (B)(4). LOT 31291123L. EVENT #5 [REDACTED NAME]: UNABLE TO MAKE THE MATRIX WITH THE ABLATION CATHETER AFTER PLACED INTO THE PATIENT. THE CATHETER WAS REMOVED AND REPLACED WITH NO HARM TO THE PATIENT. THE CATHETER WILL BE RETURNED TO THE MANUFACTURER UNDER (B)(4). LOT 31325978L. EVENT #6 [REDACTED NAME]: THERE WAS A FORCE SENSOR ERROR OF THE ABLATION CATHETER WHILE IN THE PATIENT. THE CATHETER WAS REMOVED AND REPLACED WITH NO HARM. LOT 31307821L. EVENT #7 [REDACTED NAME]: AFTER PLACEMENT INTO THE PATIENT, THE ABLATION CATHETER DISPLAYED A MAGNETIC SENSOR ERROR. THE CATHETER WAS REMOVED AND REPLACED WITH NO HARM TO THE PATIENT. LOT 31291167L. EVENT #8 [REDACTED NAME]: AFTER PLACEMENT INTO THE PATIENT, THE ABLATION CATHETER ERRORED WITH A MESSAGE: "METAL VALUE TOO HIGH". THE CATHETER WAS REMOVED AND REPLACED WITH NO HARM TO THE PATIENT. LOT 31325901L. EVENT #9 [REDACTED NAME]: THERE WAS A "D" CURVE MALFUNCTION OF THE ABLATION CATHETER. THE CATHETER WAS REMOVED AND REPLACED WITH NO HARM TO THE PATIENT. LOT 31325901L. EVENT #10 [REDACTED NAME]: AFTER PLACED INTO THE PATIENT, THE ABLATION CATHETER FORCE INDICATOR WOULD FREEZE EVERY 1/2 HOUR REQUIRING THE CATHETER TO BE RE-ZEROED. THE CATHETER WAS REMOVED AND REPLACED WITH NO HARM TO THE PATIENT. LOT 31325901L. MANUFACTURER RESPONSE FOR ABLATION CATHETER, THERMOCOOL SMARTTOUCH® SF CATHETER (PER SITE REPORTER). THEY ARE LOOKING INTO THE INCREASE IN EVENTS, NO RESPONSE YET.