BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION SYSTEM

    MDR report key: 2045763 · Received April 8, 2011

    Report

    Report Number
    3005099803-2011-01180
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT USED PAST THE EXPIRATION DATE. NOT ENOUGH GLUE APPLIED TO THE BACK OF THE PLATES TO SECURE THE PLATES TO THE HEAT EXCHANGER CARTRIDGE (HXC). THE DEVICES (HXC AND CATHETER) WERE RECEIVED FOR ANALYSIS. DURING THE INITIAL VISUAL EXAM, THERE WAS NO DAMAGE OBSERVED TO THE EXTERNAL TUBING OR THE HXC CONNECTOR. THERE WAS NO EXCESSIVE GLUE ON THE PLATE BONDS. THERE WERE NO VISIBLE DAMAGES OR IMPERFECTIONS OBSERVED ON THE PLASTIC HOUSINGS OF THE HXC CORE, RESERVOIR OR MANIFOLD. THERE WERE NO DEFECTS FOUND WITH THE RETURNED CATHETER. DURING THE PERFORMANCE TESTING, THE ANCHORING AND COMPRESSION BALLOONS INFLATED AND DEFLATED APPROPRIATELY WITH NO ISSUES ENCOUNTERED. THE HXC LEAKED DURING ANALYSIS AS WATER EMPTIED FROM THE HXC THROUGH THE BOTTOM OF THE CONSOLE. POST EVALUATION DETERMINED THIS LEAK WAS CAUSED BY THE SEPARATION OF THE PLATES TO THE HXC CORE. FURTHER ANALYSIS CONDUCTED ON THIS HXC CONFIRMED THAT THERE WAS NOT ENOUGH GLUE APPLIED TO THE BACK OF THE PLATES TO SECURE THE PLATES TO THE HXC. INADEQUATE AMOUNT OF GLUE APPLIED TO THE BACK OF THE HEATING PLATES IS A SUPPLIER MANUFACTURING RELATED ISSUE THAT CONTRIBUTED TO THE HXC LEAK. PRODUCT ANALYSIS PERFORMED ON THE RETURNED CATHETER COULD NOT DUPLICATE ANY LEAKS OR DEFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A PATIENT UNDERWENT A PROCEDURE WITH A PROLIEVE THERMODILATATION KIT FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH). REPORTEDLY, DURING THE PROCEDURE THE FOLEY/ANCHORING BALLOON DEFLATED AND THE CATHETER CAME OUT OF THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. IT WAS REPORTED THAT THE KIT WAS NOT USED PAST EXPIRY DATE. FOLLOW UP WITH THE COMPLAINANT REVEALED THEY TESTED THE CATHETER DURING SET UP AND THERE WERE NO ISSUES, THEY DID NOT CHECK FOR A LEAK. THE EVENT OCCURRED 5 - 6 MINUTES INTO THE PROCEDURE, AFTER THE MICROWAVE ENERGY WAS TURNED ON. THE PHYSICIAN PULLED ON THE CATHETER, THE CATHETER MOVED AND THEY IMMEDIATELY STOPPED THE PROCEDURE TO SWITCH OUT THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS AND PATIENT WAS FINE POST PROCEDURE.

    Description of Event or Problem · 1

    FOLLOW UP WITH THE COMPLAINANT REVEALED THAT THERE WERE FLUID LEAKS IN THE CONSOLE WHERE THE HEAT EXCHANGER CARTRIDGE (HXC) IS INSERTED. AFTER THE CASE, THE WHOLE DRAWER WAS FULL OF LIQUID FROM THE CARTRIDGE. THERE WERE NO ERROR MESSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILITATION SYSTEM SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY MEQ BOSTON SCIENTIFIC - MARLBOROUGH M0068808260

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR