BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4662416 · Received April 6, 2015

    Report

    Report Number
    9673241-2015-00192
    Event Type
    Injury
    Date Received
    April 6, 2015
    Date of Event
    March 11, 2015
    Report Date
    March 11, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CONCOMITANT PRODUCTS: CARTO 3 SYSTEM: (R10039) SMARTABLATE GENERATOR: (G4C-0314) SMARTABLATE PUMP: (G4CP-0336) SMARTTOUCH CATHETER: (D133602/17120294M) MANUFACTURER REF # PI1-RXUTW8

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, (B)(6), MALE, UNDERWENT AN ATRIAL FLUTTER RIGHT (R-AFL) PROCEDURE SUFFERED CARDIAC TAMPONADE, WHICH REQUIRED PERICARDIOCENTESIS AND 1000CC OF FLUID WERE REMOVED. ACCORDING TO THE PHYSICIAN, THE PATIENT REQUIRED SURGICAL INTERVENTION TO CLOSE A SMALL PERFORATION BETWEEN THE RIGHT ATRIUM AND VENTRICLE WHICH WAS OCCURRED BY A STEAM POP. THE PATIENT WAS STABLE AFTER SURGICAL REPAIR AND REQUIRED THREE DAYS OF EXTENDED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225525 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-02-S 17120294M

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R