BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTO RMT V8 SYSTEM

    MDR report key: 1582093 · Received January 14, 2010

    Report

    Report Number
    9681484-2010-00003
    Event Type
    Injury
    Date Received
    January 14, 2010
    Date of Event
    December 17, 2009
    Report Date
    December 17, 2009
    Manufacturer
    BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)
    Product Code
    DQK
    PMA / PMN Number
    K060047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BIOSENSE WEBSTER, INC. PROFESSIONAL EDUCATION SPECIALIST (PES), WHO WAS ON-SITE DURING ABLATION PROCEDURE, MENTIONED THAT IT WAS JUST A THIN WALL AT THE SITE OF ABLATION AND THE POSITIONING OF THE CATHETER THAT RESULTED TO PERICARDIOCENTESIS, AND NOT A PRODUCT PROBLEM. WHEN THE CUSTOMER WAS APPROACHED TO PROVIDE SERVICE AND INSPECT THE DEVICES IN CONJUNCTION WITH THIS EVENT, THE CUSTOMER DECLINED AND MENTIONED THERE IS NO NEED FOR SERVICE. THE CUSTOMER IS USING THE EQUIPMENT ON SITE. THERE IS NO FURTHER INFORMATION AVAILABLE ABOUT THE PATIENT OR THE DETAILS OF THE PROCEDURE PERFORMED IN THE OPERATING ROOM OR THEREAFTER.

    Description of Event or Problem · 1

    THE CUSTOMER FACILITY REPORTED THAT WHILE ABLATING IN THE LEFT ATRIUM FOR ATRIAL FIBRILLATION, A PERICARDIAL EFFUSION OCCURRED. TWO TRANSSEPTAL PUNCTURES WERE MADE, ONE WITH A PREFACE SHEATH. THE PHYSICIAN WAS ABLATING WITH AN F-CURVE THERMOCOOL CATHETER RANGING FROM 25 - 35 WATTS ON THE STOCKERT GENERATOR. AFTER FINISHING ISOLATING THE LEFT SIDED PULMONARY VEINS, A FEW ABLATIONS WERE MADE AROUND THE RIGHT SIDED PULMONARY VEIN WHEN THE PHYSICIAN NOTED FLUID IN THE PERICARDIAL SPACE ON ICE (BOSTON SCIENTIFIC ICE CATHETER). A DECREASE IN BLOOD PRESSURE FOLLOWED, AND A PERICARDIOCENTESIS WAS PERFORMED. THE DURATION OF THE ABLATION PROCEDURE OR THE TOTAL NUMBER OF ABLATIONS PERFORMED IS UNKNOWN. ALL CATHETERS AND PACKAGING WERE DISPOSED OF BY THE CUSTOMER. IT WAS REPORTED THAT THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM AT SOME POINT AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARTO RMT V8 SYSTEM DQK COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-5730-01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R