BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_THERMOCOOL SF NON NAV

    MDR report key: 11615224 · Received April 5, 2021

    Report

    Report Number
    2029046-2021-00508
    Event Type
    Injury
    Date Received
    April 5, 2021
    Date of Event
    December 30, 2019
    Report Date
    March 17, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, 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.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING COMPLICATIONS WERE REPORTED IN THIS PUBLICATION: IT WAS REPORTED THAT 2 PATIENTS UNDERWENT CATHETER ABLATION OF ATRIAL FIBRILLATION AND SUFFERED PERICARDIAL EFFUSION WITH PERICARDIOCENTESIS. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS OPEN IRRIGATED THERMOCOOL ABLATION CATHETER. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: ACUNAV, NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: SPIRAL; ST. JUDE MEDICAL, ST. JUDE ENSITE VELOCITY SYSTEM, TACTI-CATH; ST. JUDE MEDICAL. PUBLICATION DETAILS: TITLE: COMPARISON OF CLINICAL AND PROCEDURAL OUTCOMES BETWEEN HIGH-POWER SHORT-DURATION, STANDARD-POWER STANDARD-DURATION, AND TEMPERATURE-CONTROLLED NONCONTACT FORCE GUIDED ABLATION FOR ATRIAL FIBRILLATION. OBJECTIVE: HIGH POWER SHORT DURATION (HPSD) ABLATION IS A NOVEL STRATEGY USING CONTACT FORCE SENSING CATHETERS OPTIMIZED FOR POWER CONTROLLED RADIOFREQUENCY ABLATION FOR ATRIAL FIBRILLATION (AF). THIS STUDY INVESTIGATES THE OUTCOMES OF HPSD(50 W DELIVERED FOR UP TO 15 S, LESION SIZE INDEX OF 5¿6) COMPARED TO STANDARD POWER STANDARD DURATION (SPSD) (20¿25 W UNTIL 400¿500 GRAM SECONDS, UP TO 60 S)AND TEMPERATURE CONTROLLED NONCONTACT (TCNC) (20-40 W UP TO 60 S OF ABLATION) SETTINGS. METHODS: WE STUDIED CONSECUTIVE CASES OF PATIENTS WITH AF UNDERGOING PULMONARY VEIN ISOLATION WITH TCNC, SPSD, AND HPSD BETWEEN JANUARY 7TH, 2013 AND JANUARY11TH, 2019. PROCEDURAL DATA COLLECTED INCLUDE TIME TO ISOLATE THE LEFT (LPVT) AND RIGHT PULMONARY VEINS (RPVT), TOTAL ABLATION TIME (TAT), AND RADIOFREQUENCY ABLATION DELIVERY TIME (RADT). CLINICAL DATA COLLECTED INCLUDE SINUS RHYTHM MAINTENANCE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512930 UNK_THERMOCOOL SF NON NAV UNK OAD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R ENSITE VELOCITY SYSTEM (ST. JUDE)| SPIRAL (ST. JUDE MEDICAL)| TACTI-CATH (ST. JUDE MEDICAL)| UNK_ACUNAV