BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RPM DIAGNOSTIC REFERENCE CATHETER

    MDR report key: 1083232 · Received July 24, 2008

    Report

    Report Number
    2953184-2008-00029
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC, EP TECHNOLOGIES, INC.
    Product Code
    DRF
    PMA / PMN Number
    K992912
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE DEVICE ON 06/24/2008, THE DEVICE WAS VISUALLY INSPECTED. THE PRIMACORE ON THE 4TH TRANSDUCER WAS FOUND TORN ON THE DISTAL ASSEMBLY, EXPOSING THE POLYIMIDE, TORN PEBAX TUBING AND ELECTRICAL WIRES. THE ELECTRICAL WIRES APPEARED TO BE INTACT (NO WIRES PROTRUDING OUT). AN ELECTRICAL VERIFICATION TEST WAS PERFORMED PRIOR TO DECONTAMINATION AND ALL TRANSDUCERS CAPACITANCE AND RESISTANCE VALUES VERIFIED NORMAL. THE CATHETER WAS DECONTAMINATED AND THE DISTAL TUBING WAS DISSECTED. DURING VISUAL INSPECTION WITH A 10X MICROSCOPE, THE WASHER NEXT TO THE 4TH TRANSDUCER WAS FOUND PUSHED INSIDE THE DISTAL TUBING. A SMALL AMOUNT OF GLUE WAS PRESENT INSIDE THE DISTAL TUBING AND ON THE POLYIMIDE TUBING NEXT TO THE 4TH TRANSDUCER. DURING DHR REVIEW, THERE WERE NO MANUFACTURING ISSUES IDENTIFIED. THE MOST PROBABLE ROOT CAUSE MAY BE DUE TO POOR ADHESIVE BONDING TECHNIQUE DURING MANUFACTURING. EITHER THE ADHESIVE APPLIED TO HOLD THE ASSEMBLY TOGETHER WAS NOT SUFFICIENT OR NOT ENOUGH TIME WAS TAKEN FOR ADHESIVE SETTING. COMPLAINT HISTORY REVIEW FOUND NO SIMILAR COMPLAINTS FOR THIS PRODUCT FAMILY IN THE LAST 24 MONTHS. NO CORRECTIVE ACTION WILL BE TAKEN AS THE PRODUCTION OF THIS PRODUCT WAS DISCONTINUED IN DECEMBER 2007.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO BSC IN 2008. DURING THE PROCEDURE, THE CATHETER WAS INTRODUCED INTO A 7F SHEATH AND NO SIGNAL APPEARED. WHEN THE CATHETER WAS WITHDRAWN, IT WAS DAMAGED. ANOTHER DEVICE WAS USED AND THE PROCEDURE COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RPM DIAGNOSTIC REFERENCE CATHETER DRF BOSTON SCIENTIFIC, EP TECHNOLOGIES, INC. 1500 9525523

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CORDIS AVANT 7 FRENCH SHEATH