THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER
Report
- Report Number
- 9673241-2016-00592
- Event Type
- Death
- Date Received
- September 14, 2016
- Date of Event
- August 24, 2016
- Report Date
- August 25, 2016
- Manufacturer
- BIOSENSE WEBSTER, INC. (JUAREZ)
- Product Code
- LPB
- PMA / PMN Number
- P030031
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. CONCOMITANT PRODUCTS: STOCKERT 70 SYSTEM (MODEL# UNKNOWN SERIAL# UNKNOWN); COOLFLOW PUMP (MODEL# UNKNOWN SERIAL# UNKNOWN). THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER APPROVED UNDER P030031/S053. DUE TO THE AUGUST 2015 FDA MAINTENANCE WHERE THE 3500A CODES WERE UPDATED, THE 3500A CODES WILL BE ADDED UNTIL THE BIOSENSE WEBSTER SYSTEM IS ALSO UPDATED. THEREFORE, THE FOLLOWING CODES APPLY: (B)(4). EVENT DESCRIPTION CONTINUATION: THE POWER WAS NOT TITRATED DURING ABLATION. THERE WERE NO ERRORS REPORTED BY THE BIOSENSE WEBSTER SYSTEMS DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS LATER RECEIVED THAT THE PATIENT HAD DIED. THE PHYSICIAN SAID THE PATIENT HAD A COMPLEX HISTORY INCLUDING PULMONARY FIBROSIS AND WAS UNSURE HOW WELL THE PATIENT WOULD HAVE DONE EVEN IF THE COMPLICATION (TAMPONADE) HAD NOT HAPPENED.
ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 21, 2016: NO POST-MORTEM WAS PERFORMED. THE PHYSICIAN DOES NOT BELIEVE THAT THE PERFORMANCE OF THE PRODUCT CONTRIBUTED TO THE OUTCOME. THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 09/22/2016. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. (B)(4).
IN THE FIRST SUPPLEMENTAL REPORT, IT STATED THAT THE DEVICE WAS RETURNED FOR ANALYSIS. ON OCTOBER 20, 2016 IT WAS DISCOVERED THAT THE DEVICE RETURNED WAS AN INCORRECT DEVICE AND THE DEVICE THAT WAS RETURNED WAS NOT RELATED TO THIS COMPLAINT. AT THIS TIME, NO DEVICE HAS BEEN RECEIVED RELATED TO THIS COMPLAINT. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER'S REF. NO: (B)(4).
ORIGINALLY, WE REPORTED THAT THE DEVICE IN THE 3500A INITIAL REPORT WAS NOT APPROVED BY THE FDA. HOWEVER, BIOSENSE WEBSTER INC. CONSIDERED IT A SIMILAR DEVICE AND WAS REPORTING THE EVENT. THIS SUPPLEMENTAL IS A CORRECTION AS THE PRODUCT WAS FDA APPROVED. THEREFORE, PLEASE SEE THE CORRECTION IN BRAND NAME. FDA PRODUCT CODE, COMMON DEVICE NAME, PMA/510(K) # AND UDI#. (B)(4).
IT WAS REPORTED THAT A PATIENT, (B)(6) YEAR OLD, MALE, UNDERWENT A LEFT SIDED IDIOPATHIC VENTRICULAR TACHYCARDIA PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL NAV CATHETER AND SUFFERED A CARDIAC TAMPONADE AND DECEASED. THE CATHETER WAS ZEROED AS NORMAL. FAST ANATOMICAL MAPPING WAS DONE WHILE SUBSTRATE MAPPING AND AN AREA OF SCARRING WAS IDENTIFIED IN THE LEFT VENTRICLE. THE PHYSICIAN ABLATED AROUND A LARGE AREA OF SCARRING AROUND THE APEX. IT WAS NOTED THAT THE PATIENT HAD A LARGE APICAL ANEURYSM WHICH WAS PRE-DIAGNOSED AND AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS IN-SITU. DURING THE ABLATION PHASE, NEAR THE END OF THE CASE, THE PATIENT'S BLOOD PRESSURE DROPPED AND AN ECHOCARDIOGRAM WAS DONE. A CARDIAC TAMPONADE WAS SEEN ON ULTRASOUND. THE SMARTTOUCH CATHETER WAS NOT IN PROXIMITY TO ANOTHER CATHETER. A PERICARDIAL TAP WAS DONE TO DRAIN THE FLUID AND AN UNKNOWN AMOUNT OF FLUID WAS DRAINED. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT POST PROCEDURE. THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS PROCEDURE RELATED SPECIFICALLY DURING ABLATION. FACTORS THAT MIGHT HAVE CONTRIBUTED TO THE EVENT INCLUDE A LARGE APICAL ANEURYSM. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK 1 NEEDLE AND ALSO RETROGRADE ACCESS WAS USED. THE PATIENT DID RECEIVE ANTICOAGULANT DURING THE PROCEDURE; HOWEVER THE ACTIVATED CLOTTING TIME MAINTAINED IS UNKNOWN. A ST. JUDE MEDICAL SL1 SHEATH WAS INITIALLY USED WHICH WAS SWAPPED FOR A ST. JUDE MEDICAL AGILIS LARGE CURVE SHEATH ONCE TRANSSEPTAL WAS COMPLETE. STOCKERT SETTINGS WERE POWER CONTROL MODE, WITH A POWER CUTOFF OF 35 WATTS, DEFAULT TEMPERATURE CUT OFF 40°C COOLFLOW IRRIGATION FLOW SETTING 15ML/MIN. DURING THE EVENT THE FOLLOWING SETTINGS WERE NOTED: TEMPERATURE 30°C, IMPEDANCE 125 OHMS, POWER 35W. LAST ABLATION CYCLE TIME AT THE SITE OF INJURY WAS 1:31 MINUTES. THE POWER WAS NOT TITRATED DURING ABLATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 600811 | THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER | CARDIAC ABLATION PERCUTANEOUS CATHETER | LPB | BIOSENSE WEBSTER, INC. (JUAREZ) | D-1348-05-S | 17484392L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Death| R |