BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 12102041 · Received July 1, 2021

    Report

    Report Number
    2029046-2021-01035
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    January 8, 2021
    Report Date
    February 9, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A 70 YEAR OLD FEMALE (80KG) PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT DURING AN AFIB CASE, A PERICARDIAL EFFUSION WAS NOTICED. TACHYCARDIA WAS ON BODY SURFACE SIGNALS AND THE PATIENT HAD A DROP IN BLOOD PRESSURE. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ICE. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND ABOUT 700 ML OF FLUID WAS REMOVED SO FAR. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN THOUGHT THE PERICARDIAL EFFUSION OCCURRED FROM THE TRANSSEPTAL. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT: PATIENT SPENT ONE ADDITIONAL DAY IN THE HOSPITAL AND THE PATIENT IS NOW REPORTED TO HAVE FULLY RECOVERED. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC. (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. BWI CONDUCTED A VISUAL INSPECTION AND A REVIEW OF ALL FEATURES OF THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. VISUAL ANALYSIS OF THE RETURNED PRODUCT REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. PER THE REPORTED EVENT, SEVERAL TESTS WERE PERFORMED. THE MAGNETIC, TEMPERATURE AND FORCE FEATURES WERE TESTED, AND NO ISSUES WERE OBSERVED. IN ADDITION, THE PRODUCT WAS DEFLECTING PROPERLY. AN IRRIGATION TEST WAS MADE, AND IT FAILED SINCE IT WAS NOT IRRIGATING PROPERLY FROM ALL THE HOLES IN THE DOME. THE DOME WAS DISSECTED, AND AN FT-IR (FOURIER-TRANSFORM INFRARED SPECTROSCOPY) WAS MADE TO IDENTIFY THE MATERIAL THAT WAS A METALLIC CARBOXYLATE WHICH IS A BIOLOGICAL MATERIAL. ITS ORIGIN REMAINS UNKNOWN BUT IS NOT RELATED TO THE MANUFACTURING PROCESS. 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 (IFU) 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 ADVERSE EVENT. INVESTIGATION FINDINGS: OPERATIONAL PROBLEM IDENTIFIED (C13) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: TIP (G04129) WERE SELECTED AS RELATED TO THE BIOLOGICAL MATERIAL AND OCCLUSION AT THE CATHETER TIP. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT 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 REF. # (B)(4)

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 70 YEAR OLD FEMALE (80KG) PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT DURING AN AFIB CASE, A PERICARDIAL EFFUSION WAS NOTICED. TACHYCARDIA WAS ON BODY SURFACE SIGNALS AND THE PATIENT HAD A DROP IN BLOOD PRESSURE. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ICE. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND ABOUT 700 ML OF FLUID WAS REMOVED SO FAR. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN THOUGHT THE PERICARDIAL EFFUSION OCCURRED FROM THE TRANSSEPTAL. THIS ADVERSE EVENT WAS DISCOVERED: DURING USE (DURING CARDIOVERSION, CATHETERS WERE NOT BEING MANIPULATED AT THE TIME OF CARDIOVERSION). THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT PHYSICIAN FELT LIKE THE TAMPONADE WAS A RESULT OF A DIFFICULT TRANSSEPTAL, LIKELY THE WIRE USED TO ADVANCE COMPETITIVE SHEATH. WAS A RESULT OF THE PATIENT CONDITION AND PROCEDURE. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH ABBOTT BRK NEEDLE. PRIOR TO NOTING THE CT ABLATION WAS PERFORMED FOR 3-5 MIN. THERE WAS NO EVIDENCE OF STEAM POP. THE EVENT NOTICED DURING ABLATION PHASE. IRRIGATED CATHETER WAS USED IN THE EVENT, THE FLOW SETTING -15ML/MIN. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR AND THE PUMP SWITCHING FROM LOW TO HIGH FLOW DURING ABLATION. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. FORCE VISUALIZATION FEATURES WERE USED: GRAPH, DASHBOARD, VECTOR AND VISITAG WITH THE VISITAG MODULE PARAMETERS FOR STABILITY: RANGE: 3MM, TIME: 3 SEC, FOT 30%, TAGE SIZE: 3MM. NO ADDITIONAL FILTER WERE USED WITH THE VISITAG AND THE COLOR OPTIONS USED PROSPECTIVELY: FTI. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT: PATIENT SPENT ONE ADDITIONAL DAY IN THE HOSPITAL AND THE PATIENT IS NOW REPORTED TO HAVE FULLY RECOVERED. SINCE THIS EVENT IS LIFE-THREATENING AND REQUIRED INTERVENTIONS TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, THEN IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996251 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30537570M 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Life Threatening| H| R ABBOTT BRK NEEDLE| CARTO 3 SYSTEM| UNSPECIFIED GENERATOR| UNSPECIFIED PUMP| VISITAG MODULE| ABBOTT BRK NEEDLE| CARTO 3 SYSTEM| UNSPECIFIED GENERATOR| UNSPECIFIED PUMP| VISITAG MODULE