BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 5889768 · Received August 19, 2016

    Report

    Report Number
    2029046-2016-00105
    Event Type
    Injury
    Date Received
    August 19, 2016
    Date of Event
    March 31, 2014
    Report Date
    August 11, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING THIS EVENT (PI1-14BKFC0, (B)(4)): CATALOG: D131504. LOT NUMBER: UNK. PATIENT AGE, GENDER AND WEIGHT: MALE, (B)(6), WEIGHT UNKNOWN.

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. 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. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CANNOT BE PROVIDED. (B)(4). METHODS: NO TESTING METHODS PERFORMED (B)(4). RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (B)(4). CONCLUSION: DEVICE DISCARDED BY USER, UNABLE TO FOLLOW-UP (B)(4). (B)(4). THE DEVICE WAS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT ONE PATIENT WITH STRUCTURAL HEART DISEASE UNDERWENT RADIOFREQUENCY ABLATION PROCEDURE AND HAD RECURRENT VT AS WELL AS PALPITATION, AMAUROSIS AND SYNCOPE. THE AUTHOR ASSESSED THAT REPORTED ADVERSE EVENTS WERE NOT RELATED TO BWI DEVICES. TITLE: ¿TREATMENT OF VENTRICULAR TACHYCARDIA AND STRUCTURAL HEART DISEASE BY SUBSTRATE MODIFIED ABLATION GUIDED BY 3-DIMENSIONAL MAPPING SYSTEM IN 7 PATIENTS.¿ THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE METHODS, ELECTROPHYSIOLOGICAL CHARACTERISTICS AND TREATMENT OUTCOMES OF SUBSTRATE MODIFIED ABLATION UNDER THE GUIDANCE OF 3-DIMENSIONAL CONTACT MAPPING SYSTEM IN PATIENTS WITH VENTRICULAR TACHYCARDIA (VT) AND STRUCTURAL HEART DISEASE. THE STUDY WAS CONDUCTED DURING MAY 2013 TO MARCH 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543414 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (IRWINDALE) D-1315-04-S UNKNOWN_D-1315-04-S

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other