BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 6287274 · Received January 30, 2017

    Report

    Report Number
    9673241-2017-00077
    Event Type
    Injury
    Date Received
    January 30, 2017
    Date of Event
    January 5, 2017
    Report Date
    January 13, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: CIRCULAR ABLATION CIRC LOOP (MODEL# D-1322-14-S LOT# 17444719L), LASSO CATHETER (MODEL# D-1220-39-S LOT# 17261097L), NMARQ INTERFACE CABLE (MODEL# D-1337-01-SI LOT# 16050824L). (B)(4).

    Description of Event or Problem · 1

    DURING A CLINICAL TRIAL SPONSORED BY BWI, A (B)(6) FEMALE PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A NAVISTAR® THERMOCOOL® CATHETER AND SUFFERED A URINARY TRACT INFECTION (REQUIRING MEDICATION) AND HYPERVOLEMIA (REQUIRING MEDICATION). LESS THAN 7 DAYS POST-PROCEDURE, THE PATIENT WAS DIAGNOSED WITH A URINARY TRACT INFECTION. INTERVENTION WAS MEDICATION. ISSUE RESOLVED WITHOUT SEQUELAE. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT TO BE MODERATE IN SEVERITY, NOT SERIOUS, NOT DEVICE-RELATED, AND DEFINITELY INDEX PROCEDURE RELATED. LESS THAN 7 DAYS POST-PROCEDURE, THE PATIENT WAS DIAGNOSED WITH VOLUME OVERLOAD. INTERVENTION WAS MEDICATION. ISSUE RESOLVED WITHOUT SEQUELAE. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT TO BE MILD IN SEVERITY, NOT SERIOUS, NOT DEVICE-RELATED, AND DEFINITELY INDEX PROCEDURE RELATED. MEDICAL HISTORY INCLUDES CONGENITAL HEART DISEASE (ATRIAL SEPTAL DEFECT REPAIRED AT (B)(6)), ATRIAL FLUTTER, LEFT/RIGHT ATRIAL TACHYCARDIA, SINUS BRADYCARDIA, PAUSES, JUNCTIONAL ESCAPE BEATS, PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA, ISOLATED ACCELERATED IDIOVENTRICULAR RHYTHM, AND PREMATURE VENTRICULAR CONTRACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70768 NAVISTAR® THERMOCOOL® SIMILAR DEVICE NI75TCJH, PMA # P030031 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-00 UNKNOWN_D-1315-00

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention