BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 7397311 · Received April 4, 2018

    Report

    Report Number
    2029046-2018-01396
    Event Type
    Injury
    Date Received
    April 4, 2018
    Date of Event
    March 9, 2018
    Report Date
    March 9, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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: CARTO 3 SYSTEM (MODEL# FG540000 SERIAL# (B)(4)), SMARTABLATE GENERATOR (MODEL# M490007 SERIAL# (B)(4)), SMARTABLATE PUMP (MODEL# M490008 SERIAL# (B)(4)), REPROCESSED SOUNDSTAR CATHETER (MODEL# R10438577 LOT# 2033003), CS CATHETER (MODEL# UNKNOWN LOT# UNKNOWN). MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OBESE FEMALE PATIENT, APPROXIMATELY (B)(6), UNDERWENT AN ABLATION PROCEDURE FOR FREQUENT PREMATURE VENTRICULAR CONTRACTIONS (PVCS) WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. DURING ABLATION PHASE, AN AUDIBLE STEAM POP OCCURRED AND A PERICARDIAL EFFUSION WAS CONFIRMED VIA ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED AND YIELDED 300 ML OF FLUID. PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR A PERICARDIAL WINDOW. ALTHOUGH NOT CONFIRMED, IT IS BELIEVED THAT THE PATIENT STAYED OVERNIGHT IN THE HOSPITAL. PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. PATIENT WAS REPORTED TO BE IN STABLE CONDITION IN THE RECOVERY ROOM. PATIENT FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE DIFFICULT ANATOMY, REQUIRING THE USE OF ADDITIONAL FORCE TO STABILIZE THE CATHETER IN POSITION IN THE ABLATION AREA. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED, AS EXCESSIVE FORCE WAS APPLIED TO THE TISSUE. THERE WERE NO ISSUES OR ERRORS REPORTED ON ANY BWI PRODUCTS OR EQUIPMENT DURING THE PROCEDURE. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. AN 8.5 (B)(4) SHEATH WAS USED. GENERATOR WAS SET ON POWER CONTROL MODE AT 34-36 WATTS (AVERAGE 35), TEMPERATURE 23-24°C (AVERAGE 24°C), 110-120 OHMS (10 OHM DECREASE DURING ABLATION), CONTACT FORCE 19-46 GRAMS (AVERAGE 31 GRAMS), AND 250 GRAMS/SECOND. POWER WAS NOT TITRATED DURING ABLATION. OVERALL ABLATION TIME AT THE SITE OF INJURY WAS 17.25 SECONDS. LAST ABLATION CYCLE TIME WAS 8.02 SECONDS. THE LENGTH OF THE ABLATION CYCLE WHEN THE STEAM POP WAS OBSERVED AT THE SAME TIP POSITION WAS 8.02 SECONDS. IRRIGATED CATHETER FLOW WAS SET ON STANDARD SMARTTOUCH SF SETTINGS FOR 35 WATTS. ALTHOUGH UNCONFIRMED, IT IS BELIEVED THAT THE PATIENT RECEIVED ANTICOAGULANT (HEPARIN) AFTER GROIN ACCESS WAS ESTABLISHED. NO ACTIVATED CLOTTING TIMES (ACTS) WERE DRAWN, AS NO TRANSSEPTAL PUNCTURE WAS PERFORMED. THERE IS NO INFORMATION REGARDING SPI VALUE. SMARTTOUCH CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER. SMARTTOUCH CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE POST CATHETER CONNECTION TO THE CARTO 3 PATIENT INTERFACE UNIT. CARTO 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240401 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 17755360L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R