BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 11188647 · Received January 18, 2021

    Report

    Report Number
    2029046-2021-00068
    Event Type
    Injury
    Date Received
    January 18, 2021
    Date of Event
    December 21, 2020
    Report Date
    December 21, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6)2021, BIOSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION INDICATING THE PATIENT WAS A 68-YEAR-OLD MALE PATIENT (61KG). PATIENT¿S CONDITION HAS IMPROVED. EXTENDED HOSPITALIZATION WAS NOT REQUIRED. PHYSICIAN INDICATED THERE IS NO CAUSAL RELATIONSHIP BETWEEN THE PRODUCT AND THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(6).

    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30438485M NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(6). MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT CARDIAC ABLATION PROCEDURE FOR ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) WITH THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED COMPLETE HEART BLOCK REQUIRING SURGICAL INTERVENTION. THREE HOURS SINCE THE PROCEDURE STARTED ABLATION TO SLOW PATHWAY WAS PERFORMED WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. ONCE ABLATION WAS PERFORMED AT MULTIPLE LOCATIONS TO INDUCE TACHYCARDIA, TACHYCARDIA OCCURRED AGAIN, SO ABLATION WAS PERFORMED AGAIN AROUND THE FIRST ABLATION SITE. DURING ABLATION, THE PHYSICIAN DID NOT NOTICE THAT THE ATRIAL WAVE IN THE INTRACARDIAC ELECTRICAL POTENTIALS HAD DISAPPEARED, AND CONTINUED TO ABLATE FOR ABOUT 10 SECONDS WHERE THE ABLATION SHOULD BE STOPPED IMMEDIATELY, RESULTING IN BRADYCARDIA. AFTER WATCHING THE SITUATION FOR A WHILE, IT WAS JUDGED THAT THE ATRIUM AND VENTRICLE WERE NOT CONDUCTING 1:1 UNDER SINUS RHYTHM, AND THE AV NODE HAD A SLIGHT CONDUCTION DISORDER, AND A BODY PACEMAKER WAS PLACED AND THE PROCEDURE WAS COMPLETED. AN EXTRACORPOREAL PACEMAKER WAS PLACED BECAUSE IT WAS JUDGED THAT THE ATRIUM AND VENTRICLE DID NOT CONDUCT 1:1 UNDER SINUS RHYTHM AND A SLIGHT CONDUCTION DISORDER OCCURRED IN THE AV NODE. AFTER WATCHING THE SITUATION FOR A WHILE, IF THE AV NODE FUNCTION RECOVERS, THE EXTRACORPOREAL PACEMAKER WILL BE REMOVED. THE PHYSICIAN¿S COMMENTED THAT DURING THE ABLATION, THEY OVERLOOKED THE SIGN THAT THE ATRIAL WAVE IN THE INTRACARDIAC ELECTRICAL POTENTIALS HAD DISAPPEARED, AND THE PLACE WHERE THE ABLATION SHOULD BE STOPPED IMMEDIATELY WAS CAUSED BY CONTINUING ABLATION FOR ABOUT 10 SECONDS. THE VIEW THAT THERE IS NO CAUSAL RELATIONSHIP BETWEEN THE PRODUCT AND THIS EVENT. THE PATIENT¿S CONDITION IS UNKNOWN. THERE WAS NO REPORT OF EXTENDED HOSPITALIZATION. SINCE PACEMAKER WAS REQUIRED THIS EVENT IS CONSIDERED A COMPLETE HEART BLOCK. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. SHOULD MORE INFORMATION BECOME AVAILABLE IN THE FUTURE; THE REPORTABILITY DECISION WILL BE REASSESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82732 THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC. D134805 30438485M 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R PENTARAY NAV ECO 7FR, D, 2-6-2