THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
Report
- Report Number
- 2029046-2022-02247
- Event Type
- Injury
- Date Received
- September 17, 2022
- Date of Event
- August 22, 2022
- Report Date
- October 30, 2022
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- LPB
- UDI-DI
- 10846835010183
- PMA / PMN Number
- P030031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. INVESTIGATION IS IN PROGRESS, ONCE COMPLETED A SUPPLEMENTAL WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 29-SEP-2022. 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
THE DEVICE EVALUATION WAS COMPLETED ON 05-OCT-2022. IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT ACCESSORY PATHWAY ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. BWI CONDUCTED A GENERAL INSPECTION THROUGH THE VISUAL INSPECTION AND ALL FEATURES OF THE CATHETER TESTS. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE SMART TOUCH BIDIRECTIONAL SF CATHETER. PER THE EVENT, SEVERAL TESTS WERE PERFORMED. THE MAGNETIC, TEMPERATURE FEATURES WERE TESTED, AND NO ISSUES WERE OBSERVED. IN ADDITION, THE PRODUCT WAS DEFLECTING AND IRRIGATING CORRECTLY. THE SCREENING TEST WAS PERFORMED ON CARTO, AND THE DEVICE FAILED. ERROR 106 WAS OBSERVED. THE DEVICE WAS DISSECTED ON THE TIP AREA; LOSS OF ELECTRICAL CONTINUITY AT THE SENSOR WAS FOUND, IT WAS DETERMINED THAT THE ROOT CAUSE WAS AN INTERNAL FAILURE OF THE SENSOR. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. AS PART OF BWI¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE INSTRUCTIONS FOR USE STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. EXPLANATION OF CODES: INVESTIGATION FINDINGS: NO DEVICE PROBLEM FOUND (C19) / INVESTIGATION CONCLUSIONS: NO PROBLEM DETECTED (D14) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿ADVERSE EVENT¿. INVESTIGATION FINDINGS: OPEN CIRCUIT (C0205)/ INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: SENSOR ((B)(6)) WERE SELECTED AS RELATED TO THE BIOSENSE WEBSTER¿S INC. PRODUCT ANALYSIS OBSERVED ¿FORCE SENSOR ¿ INTERNALLY DAMAGED¿ ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT ACCESSORY PATHWAY ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING USING A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER IN THE LEFT ATRIUM, A TAMPONADE OCCURRED. PLEASE NOTE THAT THE TAMPONADE WAS NOT CAUSED BY THE BIOSENSE WEBSTER, INC. EQUIPMENT. THE PHYSICIAN ASSUMED THAT THE 4 POLE BIOTRONIK CATHETER (RV CATHETER) WAS THE PROBLEM AND CAUSED THE TAMPONADE AND NOT THE BIOSENSE WEBSTER ABLATION CATHETER. THE PHYSICIAN THINKS, THAT THE ADVERSE EVENT WAS CAUSED BY THE CATHETER OF BIOTRONIK (NOT THE BIOSENSE WEBSTER PRODUCT) IN COMBINATION WITH THE PATIENT¿S CONDITION. BECAUSE THE PHYSICIAN DETECTED A SMALL PERFORATION IN THE RIGHT VENTRICLE, WHERE THE BIOTRONIK CATHETER WAS LOCALIZED. THE BIOSENSE WEBSTER CATHETER WAS ONLY IN THE LEFT ATRIUM. THE SURGERY WAS DELAYED 5 MINUTES DUE TO THE REPORTED EVENT. AFTER DETECTION OF THE TAMPONADE, THEY STOPPED THE PROCEDURE. THEY HAD TO CANCEL THE CASE, SO THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. THEY PERFORMED A PUNCTURE OF THE PERICARDIUM. ADDITIONALLY, IT WAS REPORTED THAT THE NGEN GENERATOR SOMETIMES SHOWED A CONSOLE MALFUNCTION 165 AND STOPPED ABLATION. EACH TIME THEY WERE PRESSING THE PEDAL, THE ABLATION WAS STARTING BUT STOPPING AGAIN AS THE ERROR WAS COMING BACK EACH TIME. RESTARTING THE NGEN GENERATOR DID NOT SOLVE THE ERROR. THE CARTO 3 SYSTEM SHOWED NO ERRORS. A BIOSENSE WEBSTER, INC. ABLATION CATHETER WAS INVOLVED IN THE PROCEDURE. THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER, INC. PRODUCTS. INTERVENTION BEING CONDUCTED WAS MAPPING A LEFT ACCESSORY PATHWAY IN THE LEFT ATRIUM. THE PATIENT OUTCOME OF THE ADVERSE EVENT IS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. NO OTHER RELEVANT HISTORY. NO BIOSENSE MATERIAL WAS USED FOR TRANSEPTAL PUNCTURE. PRIOR TO NOTING THE CARDIAC TAMPONADE, ABLATION WAS PERFORMED. THERE WAS NO EVIDENCE OF STEAM POP. THE EVENT OCCURRED DURING THE ABLATION PHASE. THE FLOW SETTINGS WERE AS RECOMMENDED. CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PUMP WAS SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. THE ONLY ERROR THEY GOT WAS ¿CONSOLE MALFUNCTION ERROR 165¿ ON THE NGEN MONITOR. VECTOR AND VISITAG FORCE VISUALIZATION FEATURES WERE USED. THE VISITAG MODULE WAS USED, PARAMETERS FOR STABILITY USED WERE 4 MM MAXIMUM DISTANCE CHANGE; 3 SEC MINIMUM TIME; 3 MM VISITAG RADIUS; 350 ¿ 440 AI. ADDITIONAL FILTER USED WITH THE VISITAG WAS 350 ¿ 440 AI. AI COLOR OPTION WAS USED PROSPECTIVELY. SINCE THE ADVERSE EVENT WAS LIFE THREATENING AND IT MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR IT COULD REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE. THE 165 ERROR CODE AND THE FOOT PEDAL PROBLEM WERE ASSESSED AS NOT MDR REPORTABLE. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124802 | THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER | CARDIAC ABLATION PERCUTANEOUS CATHETER | LPB | BIOSENSE WEBSTER INC | D134805 | 30818145L | 10846835010183 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention| L | CARTO 3 SYSTEM| NGEN PUMP, EU CONFIGURATION| NGEN RF GENERATOR| NON BWI-BIOTRONIK 4 POLE CATHETER| UNK_CARTO 3 |