BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 6484539 · Received April 11, 2017

    Report

    Report Number
    9673241-2017-00272
    Event Type
    Death
    Date Received
    April 11, 2017
    Date of Event
    March 16, 2017
    Report Date
    March 17, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CAN NOT BE PROVIDED. CONCOMITANT MEDICAL PRODUCTS: CARTO 3 SYSTEM, MODEL #:M-4800-01, SERIAL #: (B)(4); SMARTABLATE GENERATOR, MODEL #: UNKNOWN, SERIAL #: UNKNOWN; SMARTABLATE PUMP, MODEL #: UNKNOWN, SERIAL #: UNKNOWN; PENTARAY NAVIGATIONAL ECO CATHETER, MODEL #: D-1282-08-S, LOT #: UNKNOWN; SOUNDSTAR ECO CATHETER, MODEL #: M-5723-16, LOT #: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR NON-ISCHEMIC VENTRICULAR TACHYCARDIA WITH A THERMOCOOL SMARTTOUCH BI-DIRECTIONAL SF CATHETER AND SUFFERED DEATH. ABLATION PROCEDURE WAS SUCCESSFULLY COMPLETED. THREE HOURS POST-PROCEDURE, THE PATIENT EXPIRED. THERE WERE NO REPORTED INDICATIONS AS TO THE CAUSE OF DEATH. IT WAS NOTED THAT THE PATIENT HAD A COMPLICATED MEDICAL HISTORY TO INCLUDE AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND AN IMPELLA VENTRICULAR ASSIST DEVICE (VAD). PHYSICIAN INDICATED THAT THEY DID NOT BELIEVE THE DEATH TO BE RELATED TO BIOSENSE WEBSTER, INC. PRODUCTS. NO FURTHER INFORMATION IS AVAILABLE REGARDING THE PHYSICIAN¿S OPINION. SINCE THIS EVENT RESULTED IN THE PATIENT¿S DEATH, IT IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265540 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-05-S UNKNOWN_D-1348-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Death