BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WITH THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 10853175 · Received November 17, 2020

    Report

    Report Number
    2029046-2020-01747
    Event Type
    Injury
    Date Received
    November 17, 2020
    Date of Event
    October 23, 2020
    Report Date
    October 23, 2020
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT ((B)(6)- YEAR OLD) UNDERWENT CARDIAC ABLATION PROCEDURE FOR IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) WITH THERMOCOOL(R) SMART TOUCH(R) SF BI-DIRECTIONAL NAVIGATION CATHETER, AND SUFFERED COMPLETE HEART BLOCK REQUIRING SURGICAL INTERVENTION. IT WAS REPORTED THAT AFTER 2 SECONDS OF RADIOFREQUENCY (RF) DURING A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION THE PATIENT WENT INTO COMPLETE HEART BLOCK. THE PHYSICIAN WILL BE INSERTING A BI-VENTRICULAR (BIV) PACEMAKER. THE CATHETER WILL BE RETURNED FOR ANALYSIS. PATIENT WAS STABLE AT THE TIME OF THE CALL. MAPPING OF THE PVC WAS PERFORMED IN THE AORTIC ROOT AND BELOW THE AORTIC VALVE IN THE LEFT VENTRICLE. EARLIEST ACTIVATION OF THE PVC WAS DETERMINED. THE HIS POTENTIALS WERE MAPPED AND TAGGED. THE ARE OF EARLIEST ACTIVATION FOR THE PVC DID NOT DISPLAY A HIS POTENTIAL. RF ABLATION WAS PERFORMED AT THE SITE OF EARLIEST PVC ACTIVATION. JUNCTIONAL RHYTHM WAS SEEN DURING ABLATION AND THE RF ENERGY WAS TURNED OFF. ABLATION TIME WAS APPROXIMATELY 2 SECONDS. THIRD DEGREE HEART BLOCK WAS SEEN AFTER ABLATION WAS STOPPED. NO FURTHER PVCS WERE SEEN. WHEN THE 3RD DEGREE BLOCK DID NOT RESOLVE THE PATIENT WAS PREPPED FOR PACEMAKER. THE PHYSICIAN CONSIDERS PROCEDURE AS THE CAUSE OF THE EVENT. PVC ABLATION WAS SUCCESSFUL, THEREFORE THE PATIENT CONDITION HAS IMPROVED. PERMANENT PACEMAKER PLACEMENT RESULTED IN OVERNIGHT STAY, THIS MAY NOT HAVE BEEN AN INCREASE FROM THE ORIGINAL INTENDED CARE PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318178 WITH THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention