THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
Report
- Report Number
- 2029046-2024-01250
- Event Type
- Injury
- Date Received
- April 16, 2024
- Date of Event
- March 19, 2024
- Report Date
- April 16, 2024
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- LPB
- UDI-DI
- 10846835010176
- PMA / PMN Number
- P030031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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).
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS. AFTER COMPLETING THE WIDE AREA CIRCUMFERENTIAL ABLATION (WACA) LINES ON BOTH LEFT AND RIGHT VEINS (151 RADIOFREQUENCY (RF) ABLATIONS APPLIED), AN ABLATION WAS PERFORMED ON THE CARINA OF THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). A PERICARDIAL EFFUSION WAS THEN NOTED INCIDENTALLY ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING. NO PATIENT SIGNS/SYMPTOMS. A PERICARDIOCENTESIS WAS PERFORMED, 500 ML OF FLUID WAS REMOVED. THE CALLER REPORTED THAT THERE WAS AN EFFUSION NOTED PRE-TRANSSEPTAL ACCESS- THE CALLER STATED THAT THIS WAS "MINOR". THE PATIENT IS CURRENTLY STABLE. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. A VISUAL INSPECTION AND REVISION OF ALL FEATURES WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE FEATURES WERE REVIEWED, AND NO ISSUES WERE OBSERVED DURING THE PRODUCT INVESTIGATION. ON 16-APR-2024, THE DEVICE LOT NUMBER WAS VERIFIED DURING PRODUCT EVALUATION AS 31259963L. SINCE THE LOT NUMBER WAS IDENTIFIED, A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS. 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. THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PROCEDURE. THE INSTRUCTION FOR USE (IFU) CONTAINS THE FOLLOWING WARNING AND PRECAUTIONS: WHEN USING THE CATHETER WITH CONVENTIONAL SYSTEMS (USING FLUOROSCOPY TO DETERMINE CATHETER TIP LOCATION), OR WITH THE CARTO¿ 3 SYSTEM, CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER WHEN RESISTANCE IS ENCOUNTERED. THE FIRMNESS OF THE BRAIDED TIP DICTATES THAT CARE MUST BE TAKEN TO PREVENT PERFORATION OF THE HEART. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 AN ATRIAL FIBRILLATION ABLATION WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS. AFTER COMPLETING THE WIDE AREA CIRCUMFERENTIAL ABLATION (WACA) LINES ON BOTH LEFT AND RIGHT VEINS (151 RADIOFREQUENCY (RF) ABLATIONS APPLIED), AN ABLATION WAS PERFORMED ON THE CARINA OF THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). A PERICARDIAL EFFUSION WAS THEN NOTED INCIDENTALLY ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING. NO PATIENT SIGNS/SYMPTOMS. A PERICARDIOCENTESIS WAS PERFORMED, 500 ML OF FLUID WAS REMOVED. THE CALLER REPORTED THAT THERE WAS AN EFFUSION NOTED PRE-TRANSSEPTAL ACCESS- THE CALLER STATED THAT THIS WAS "MINOR". THE PATIENT IS CURRENTLY STABLE. THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PROCEDURE RELATED. THE PHYSICIAN WAS VERY SURPRISED AND INDICATED THAT HE DID NOT FEEL A STEAM POP OR SEE ANY FLICKS. NO MAJOR INCREASES/DECREASES IN IMPEDANCE. CASE WAS GOING SMOOTHLY. THE PATIENT FULLY RECOVERED AND WAS STABILIZED ON TABLE WITH NO MAJOR IMPACT TO BLOOD PRESSURE THROUGHOUT THE PERICARDIOCENTESIS. TRANSSEPTAL PUNCTURE WAS PERFORMED. ABLATION WAS PERFORMED PRIOR TO NOTING THE PERICARDIAL EFFUSION (COMPLETE WACA ON BOTH LEFT AND RIGHT VEINS).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1407713 | THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER | CARDIAC ABLATION PERCUTANEOUS CATHETER | LPB | BIOSENSE WEBSTER INC | 31259963L | 10846835010176 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male | Required Intervention| L | BAYLIS VERSACROSS. REF: VXSK0024| CARTO 3 SYSTEM| NGEN PUMP, US CONFIGURATION| NGEN RF GENERATOR, US| STERILMED REPROCESSED CS CATHETER| STERILMED REPROCESSED SOUNDSTAR| UNK_CARTO VIZIGO SHEATH| UNK_OCTARAY NAV |