BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BI DIR 7FR DEFL CS CATH, NON-

    MDR report key: 9454676 · Received December 11, 2019

    Report

    Report Number
    2029046-2019-03984
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Date of Event
    November 18, 2019
    Report Date
    November 18, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835002416
    PMA / PMN Number
    K090898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY (CS) CATHETER AND A THROMBUS ISSUE OCCURRED. THE PHYSICIAN NOTICED VIA INTRA-CARDIAC ULTRASOUND THAT A CLOT HAD FORMED ON THE PROXIMAL ELECTRODES ON THE CS CATHETER. THE INVESTIGATIONAL ANALYSIS COMPLETED 12/26/2019. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE AND IT WAS FOUND WITHIN SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE CATHETER PASSED ALL SPECIFICATIONS. MANUFACTURE REFERENCE NO: (B)(4).

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. UPON INITIAL VISUAL INSPECTION, NO DAMAGE OR ANOMALIES OBSERVED. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY (CS) CATHETER AND A THROMBUS ISSUE OCCURRED. THE PHYSICIAN NOTICED VIA INTRA-CARDIAC ULTRASOUND THAT A CLOT HAD FORMED ON THE PROXIMAL ELECTRODES ON THE CS CATHETER. WHEN THE CATHETER WAS REMOVED, PROXIMAL ELECTRODES DEFORMITY WAS ALSO NOTICED. THE PROCEDURE WAS THEN CANCELLED. NO PATIENT INJURY WAS REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL DETAILS. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE OBSERVED THROMBUS HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246087 BI DIR 7FR DEFL CS CATH, NON- ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER INC 30251184M 10846835002416

    Patients

    Seq Age Sex Outcome Treatment
    1