BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 6691897 · Received July 6, 2017

    Report

    Report Number
    2029046-2017-00226
    Event Type
    Injury
    Date Received
    July 6, 2017
    Date of Event
    June 12, 2017
    Report Date
    January 22, 2018
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    OAD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON JANUARY 22, 2018, DEACTIVATING THE DYSPNEA AND THORACIC PRESSURE EVENTS WHICH WERE PREVIOUSLY REPORTED. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON JULY 25, 2017. THE PATIENT WAS A (B)(6) FEMALE WITH A PRE-PROCEDURE DIAGNOSIS OF PAROXYSMAL ATRIAL FIBRILLATION. VISITAG FORCE VISUALIZATION FEATURE WAS USED DURING THE PROCEDURE WITH THE FOLLOWING PARAMETERS: 2-3 MM STABILITY RANGE AND 3-5 SEV STABILITY TIME. THE ADVERSE EVENT OCCURRED ONE DAY POST ABLATION. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS PROBABLY PROCEDURE RELATED. NO MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. THE DIAPHRAGMATIC PARALYSIS RESOLVED WITHOUT SEQUELAE AND THE PATIENT HAS SINCE FULLY RECOVERED WITH NO RESIDUAL EFFECTS. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 07/28/2017 THAT THIS ACCOUNT ((B)(6)) USES A SMARTTOUCH CATALOG # D132705. PER THE ADDITIONAL INFORMATION RECEIVED, THE DEVICE WAS UPDATED FROM NAVISTAR THERMOCOOL CATALOG# NI75TCJHI TO SMART TOUCH BIDIRECTIONAL CATALOG# D132705. THE LOT NUMBER REMAINS UNKNOWN. (B)(4).

    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 (MODEL# M-4800-01 SERIAL# (B)(4)). MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    DURING A CLINICAL TRIAL, SPONSORED BY BWI, IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A NAVISTAR® THERMOCOOL® CATHETER AND SUFFERED DIAPHRAGMATIC PARALYSIS. POST-PROCEDURE, THE PATIENT DEVELOPED REDUCED MOBILITY OF THE RIGHT HEMIDIAPHRAGM. THERE IS NO INFORMATION REGARDING INTERVENTIONS OR EXTENDED HOSPITALIZATION. ISSUE IS ONGOING AND UNCHANGED. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS PROBABLY PROCEDURE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469566 NAVISTAR® THERMOCOOL® SIMILAR DEVICE NI75TCJH, PMA # P030031 OAD BIOSENSE WEBSTER, INC. (IRWINDALE) D-1197-18-SI UNKNOWN_D-1197-18-SI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other