BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 6691175 · Received July 6, 2017

    Report

    Report Number
    2029046-2017-00225
    Event Type
    Injury
    Date Received
    July 6, 2017
    Date of Event
    June 15, 2017
    Report Date
    June 19, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    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 JULY 10, 2018. THE CHEST PAIN AND HYPOTENSION SEVERITY LEVEL WAS UPDATED FROM SEVERE TO MODERATE. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON DECEMBER 27, 2017. THE PATIENT OUTCOME HAS RESOLVED WITHOUT SEQUELAE. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 1

    IN THE INITIAL 3500A, THE DEVICE HISTORY RECORD INFORMATION WAS OMITTED IN ERROR. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. (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# D-1197-18-SI 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. 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¿HERMOCOOL¿ATHETER AND SUFFERED HYPERTENSION, CHEST PAIN/DISCOMFORT, AND CONGESTIVE HEART FAILURE. DURING THE PROCEDURE, AFTER THE USE OF PROTAMINE, THE PATIENT DEVELOPED ACUTE HYPERTENSION. ISSUE RESOLVED WITHOUT SEQUELAE. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS DEFINITELY PROCEDURE-RELATED. POST-PROCEDURE, THE PATIENT REPORTED CHEST PAIN/DISCOMFORT. ISSUE RESOLVED WITHOUT SEQUELAE. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS DEFINITELY PROCEDURE-RELATED. POST-PROCEDURE, THE PATIENT DEVELOPED CONGESTIVE HEART FAILURE. 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
    471222 NAVISTAR® THERMOCOOL® SIMILAR DEVICE NI75TCJH, PMA # P030031 LPB BIOSENSE WEBSTER, INC. (IRWINDALE) D-1197-18-SI UNKNOWN_D-1197-18-SI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SEE SECTION H10.