BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL CATHETER

    MDR report key: 17194938 · Received June 23, 2023

    Report

    Report Number
    2029046-2023-01375
    Event Type
    Injury
    Date Received
    June 23, 2023
    Date of Event
    May 26, 2023
    Report Date
    July 20, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 23-JUN-2023, THE PRODUCT INVESTIGATION WAS UPDATED TO INCLUDE THE MRE (MANUFACTURING RECORD EVALUATION). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31016719L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. EXPIRATION DATE: 11-APR-2026. MANUFACTURED DATE: 12-APR-2023. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4) PER INTERNAL REVIEW, IT WAS DETERMINED THAT A PROLONGED HOSPITALIZATION OCCURRED AND WAS NOT CHECKMARKED IN SECTION B2 OF THE INITIAL REPORT. THIS SUPPLEMENTAL REPORT HAS BEEN CHECKMARKED ACCORDINGLY. ADDITIONALLY, THE H6 HEALTH EFFECT - IMPACT CODE FOR "HOSPITALIZATION OR PROLONGED HOSPITALIZATION (F08)" WAS UPDATED AS WELL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA CARDIAC ABLATION PROCEDURE WITH THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL CATHETER. THE PATIENT SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. INTRAOPERATIVE INTRAPERICARDIAL ECHOCARDIOGRAPHY SHOWED WHAT APPEARED TO BE PERICARDIAL FLUID DURING THE PROCEDURE. PERICARDIOCENTESIS WAS PERFORMED FOLLOWED BY DRAINAGE. ABLATION WAS PERFORMED BEFORE PERICARDIAL EFFUSION OR TAMPONADE WAS DETECTED. NO STEAM POP CONFIRMED. AN IRRIGATION CATHETER WAS USED WITH THE FOLLOWING FLOW SETTING: LOW FLOW RATE 2 ML/M, 8 ML/M BELOW 30W, 15 ML/M OVER 30W. DRAINAGE WAS PERFORMED DUE TO PERICARDIAL EFFUSION. PATIENT¿S CURRENT CONDITION: BLOOD PRESSURE DID NOT DECREASE. PHYSICIAN ASSESSMENT OF THE HEALTH PROBLEM: NON-SERIOUS (MODERATE/MINOR) CF MONITORING METHODS REAL TIME GRAPH; DASHBOARD; VECTOR; VISITAG. CAUSAL RELATIONSHIP WITH PRODUCT: UNKNOWN ADDITIONAL INFORMATION: PATIENT HAS FULLY RECOVERED. A TRANSSEPTAL PUNCTURE WAS PERFORMED BY RF NEEDLE. THE EVENT OCCURRED DURING ABLATION PHASE. MEDICAL HX: MYOCARDIAL INFARCTION. THE ADVERSE EVENT OCCURRED ON (B)(6) 2023. THE EVENT OCCURRED DURING USE OF THE BWI PRODUCTS. THE LIQUID FOUND DURING THE PROCEDURE WAS NOT A PERICARDIAL FLUID, BUT SALINE SOLUTION FROM OCR. WHEN CONFIRMED BY SOUND STAR CATHETER IMMEDIATELY AFTER THE OCR ENTERED TO PERICARDIAL SPACE, NO PERICARDIAL EFFUSION WAS FOUND. WHEN THE OCR WAS PULLED OUT FROM PERICARDIAL SPACE AT THE TIME OF PROCEDURE COMPLETION, SOUND STAR FOUND THE PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS PERFORMED AND DRAINED A LIQUID WITH SMALL AMOUNT OF BLOOD. PERICARDIOCENTESIS WAS PERFORMED FOLLOWED BY DRAINAGE. THE PATIENT OUTCOME OF THE ADVERSE EVENT WAS RECOVERY. THE PATIENT REMAINED IN THE HOSPITAL AT THE TIME OF REPORT SINCE A DISCHARGE DATE HAD NOT BEEN PLANNED PRIOR. A TRANSSEPTAL PUNCTURE WAS PERFORMED BY RF NEEDLE. THE RELEVANT FLOW SETTINGS WERE: LOW FLOW: 2ML/MIN, BELOW 30W: 8ML/MIN, ABOVE 30W: 15ML/MIN. THE CORRECT GENERATOR SETTINGS WERE USED. THE PUMP WAS ABLE TO SWITCH FROM "LOW" TO "HIGH" FLOW DURING ABLATION. THE FOLLOWING FORCE VISUALIZATION FEATURES WERE USED: REAL TIME GRAPH, DASHBOARD, VECTOR, VISITAG. THE VISITAG PARAMETERS WERE 2MM, TIME:3S, FOT:25%.3G, TAG SIZE:2MM. ADDITIONAL FILTER WAS NOT USED WITH THE VISITAG. SINCE THE EVENT IS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279198 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 31016719L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| L| R CARTO 3 SYSTEM| CARTO VISITAG MODULE| OCTARAY CATHETER| SOUNDSTAR ECO CATHETER| UNSPECIFIED RF NEEDLE