BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 11449117 · Received March 9, 2021

    Report

    Report Number
    2029046-2021-00327
    Event Type
    Injury
    Date Received
    March 9, 2021
    Date of Event
    February 17, 2021
    Report Date
    February 17, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DEVICE IS NOT AVAILABLE FOR RETURN, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURER RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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 (B)(6) OLD FEMALE PATIENT ((B)(6) KG) WITH A HISTORY OF CONGENITAL HEART DEFECT, SINGLE VENTRICLE S/P GLENN (CARDIAC SURGERY) UNDERWENT A ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT) AND WOLFF-PARKINSON-WHITE (WPW) WITH AN UNSPECIFIED THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND EXPERIENCED HEART BLOCK. DURING THE ABLATION WHEN RADIOFREQUENCY (RF) IS ON, THE BACK PATCH DISPLAYS A BACK PATCH DETACHED ERROR. PATCH PLACEMENT IS LIMITED BASED ON PATIENT SIZE. THE PATCHES AND CABLES SEEM TO BE ISOLATED FROM EACH OTHER AND THE INDIFFERENT ELECTRODE IS ON THE RIGHT LEG. A SECOND INDIFFERENT ELECTRODE WAS ADDED WITHOUT RESOLUTION. THE PATCHES WERE REPLACED. THE BACK- PATCH SENSOR CABLE WAS REPLACED, AND THE CARTO 3 SYSTEM WAS REBOOTED. THE CALLER STATED THAT THE REPLACEMENT PATCH SENSOR CABLE WAS DIFFICULT TO SEAT IN THE PATCH UNIT THEN A 1006 ERROR DISPLAYED AFTER THE CABLE REPLACEMENT. THE ORIGINAL SENSOR CABLE WAS CONNECTED BACK TO THE PIU/PATCH UNIT AND THE 1006 RESOLVED. AFTER 11 SECONDS OF RF A SMALL STEAM POP OCCURRED THEN 2:1 HEART BLOCK WHICH RESOLVED WITHIN A FEW MINUTES. A BACK PATCH 3 DISCONNECT ERROR WAS THEN DISPLAYED ON THE CARTO 3. THE OUTCOME OF THE ADVERSE EVENT: FULLY RECOVERED NO ADVERSE EVENTS NOTED. SINCE THE EVENT IS LIFE-THREATENING AND REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, THEN IT IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342217 THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LYB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other