BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 5999951 · Received October 5, 2016

    Report

    Report Number
    9673241-2016-00657
    Event Type
    Death
    Date Received
    October 5, 2016
    Date of Event
    September 9, 2016
    Report Date
    September 19, 2016
    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
    NY, 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. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM. CIRCA SCIENTIFIC MULTIPOLAR TEMPERATURE PROBE. FULL UDI # INFORMATION UNAVAILABLE SINCE THE LOT NUMBER IS UNKNOWN. (B)(4). ARE RELATED TO THE SAME INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED AN ESOPHAGEAL FISTULA RESULTING IN THE PATIENT'S DEATH. POST-PROCEDURE, AN ESOPHAGEAL FISTULA WAS DIAGNOSED. THE DEATH TOOK PLACE AN UNKNOWN AMOUNT OF TIME AFTER. THERE IS NO INFORMATION REGARDING THE DETAILED COURSE OF EVENTS OR AN AUTOPSY. PHYSICIAN'S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED AND NOT THE RESULT OF A PRODUCT MALFUNCTION. PHYSICIAN IS NOT CERTAIN WHICH ABLATION SITE WAS THE SITE OF INJURY. GENERATOR WAS IN POWER CONTROL MODE AT 35 WATTS ON THE ANTERIOR WALL AND 20-25 WATTS ON THE POSTERIOR WALL. TEMPERATURE WARNING WAS SET AT 45 DEGREES CELSIUS AND CUT-OFF AT 50 DEGREES CELSIUS. ABLATION TIME AT THE SITE OF INJURY WAS NOT REPORTED, AS THERE WERE NO PROLONGED ABLATION SITES ASSOCIATED WITH INCREASED TEMPERATURES. CIRCA SCIENTIFIC MULTIPOLAR TEMPERATURE PROBE WAS USED TO PREVENT ESOPHAGEAL INJURY. ATTEMPTS WERE MADE TO AVOID THE ESOPHAGUS WHILE COMPLETING A POSTERIOR BOX. SPI VALUE IS UNKNOWN. THE THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER. THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE, POST-CONNECTION TO THE CARTO 3 PIU. CARTO 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. THERE WERE NO ERRORS REPORTED ON ANY BWI EQUIPMENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652461 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S UNK_D-1327-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death