BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6307466 · Received February 7, 2017

    Report

    Report Number
    9673241-2017-00096
    Event Type
    Death
    Date Received
    February 7, 2017
    Date of Event
    December 31, 2015
    Report Date
    January 17, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCTS THAT USED IN THIS STUDY: CARTO SYSTEM, LASSO CATHETER OTHER COMPANY¿S DEVICES THAT WERE USED IN THIS STUDY: DIAGNOSTIC ULTRASOUND CATHETER(5.5¿10 MHZ,8F,ACUNAV,SIEMENS MEDICAL), NAVX (ST. JUDE MEDICAL). (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 1 PATIENT WITH PRIOR MITRAL VALVE SURGERY UNDERWENT RADIOFREQUENCY CATHETER ABLATION FOR SYMPTOMATIC ATRIAL ARRHYTHMIAS AND SUFFERED INTRACEREBRAL BLEEDING IDENTIFIED IMMEDIATELY POST-PROCEDURE AND LEADING TO INHOSPITAL DEATH. ADDITIONAL INFORMATION WAS OBTAINED FROM AUTHOR: BWI DEVICE CITED IN THE ARTICLE DID NOT LED TO THE REPORTED PATIENT CONSEQUENCES. PHYSICIAN STATED THAT THE CAUSALITY OF ADVERSE EVENT WAS PROCEDURE-RELATED. THE CATHETERS USED IN THIS PROCEDURE WERE NOT REPROCESSED / REUSED CATHETERS. INTRACEREBRAL BLEEDING EVENT RESULTED SEVERE DAMAGE (DEATH). (B)(6) YEAR OLD FEMALE ((B)(6) POUNDS) PATIENT WITH ACUTE MENTAL STATUS CHANGE SHORTLY FOLLOWING PROCEDURE, CT SCAN WITH ICH. PATIENT HAD HEMICRANIOTOMY BUT NEVER REGAINED NEUROLOGIC FUNCTION AND DIED IN THE HOSPITAL ON (B)(6) 2014, 12 DAYS AFTER ABLATION PROCEDURE. TITLE: ¿POSTOPERATIVE ATRIAL TACHYCARDIAS AFTER MITRAL VALVE SURGERY: MECHANISMS AND OUTCOMES OF CATHETER ABLATION.¿ THE PURPOSE OF THIS STUDY WAS TO DETERMINE THE ELECTROPHYSIOLOGICAL MECHANISMS OF AT IN PATIENTS WITH PRIOR MV SURGERY AND THE LONG-TERM OUTCOMES OF CATHETER ABLATION. 67 PATIENTS WERE ENROLLED IN THIS STUDY BETWEEN JANUARY 2007 AND DECEMBER 2015. SUSPECT DEVICE IS 3.5-MM IRRIGATED-TIP THERMOCOOL ABLATION CATHETER, HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89626 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-00 UNKNOWN_D-1336-00

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death