BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION SYSTEM

    MDR report key: 1925607 · Received December 14, 2010

    Report

    Report Number
    3005099803-2010-05143
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED PROLIEVE THERMODILATATION SYSTEM CATHETER REVEALED NO PHYSICAL SIGNS OF DAMAGE. FUNCTIONAL ANALYSIS REVEALED THAT WHILE INJECTING WATER INTO THE ANCHORING BALLOON PORT, THE COMPRESSION BALLOON BEGAN TO FILL. THE COMPRESSION BALLOON CONTINUED TO FILL FOLLOWED BY THE ANCHORING BALLOON. THE ANCHORING BALLOON WAS REMOVED OFF THE CATHETER AND IT WAS OBSERVED THAT THERE WAS STILL PLASTIC IN THE DRILL HOLE AND BLOCKING THE PORT THAT SHOULD HAVE BEEN REMOVED DURING MANUFACTURING. THE CATHETER LUMENS WERE DISSECTED. IT WAS OBSERVED THAT THERE WAS A HOLE IN THE ANCHORING BALLOON LUMEN CAUSING WATER TO GO INTO THE CENTER (RETURN) LUMEN, UP TO THE TIP AND DOWN THE COMPRESSION BALLOON LUMENS WHICH THEREFORE CAUSED THE COMPRESSION BALLOON TO FILL WHILE TRYING TO FILL THE ANCHORING BALLOON. THIS TEAR WAS MOST LIKELY CAUSED BY THE DOCTOR WHEN HE INSERTED A GUIDEWIRE TO DEFLATE THE ANCHORING BALLOON. THE REPORTED EVENT OF THE ANCHORING BALLOON WOULD NOT DEFLATE WAS CONFIRMED. THE ROOT CAUSE FOR THIS EVENT IS SUPPLIER MANUFACTURING AS THE ANALYSIS SHOWED THAT THE BALLOON PORT WAS BLOCKED WITH REMNANT FROM THE DRILL HOLE LEFT DURING MANUFACTURING. THIS BLOCKAGE CAUSED THE ANCHORING BALLOON NOT TO DEFLATE WHILE INSIDE THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROLIEVE THERMODILATATION SYSTEM KIT WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN WAS UNABLE TO DEFLATE THE ANCHORING BALLOON. THE PHYSICIAN INSERTED A GUIDEWIRE, REMOVED THE BLOCKAGE AND DEFLATED THE BALLOON AND REMOVED THE PROLIEVE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROLIEVE THERMODILATATION KIT. THERE WERE NO COMPLICATIONS AND THE PATIENT'S CONDITION WAS REPORTED AS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROLIEVE THERMODILATATION SYSTEM KIT WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN WAS UNABLE TO DEFLATE THE ANCHORING BALLOON. THE PHYSICIAN INSERTED A GUIDEWIRE, REMOVED THE BLOCKAGE AND DEFLATED THE BALLOON AND REMOVED THE PROLIEVE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROLIEVE THERMODILATATION KIT. THERE WERE NO COMPLICATIONS AND THE PATIENT'S CONDITION WAS REPORTED AS GOOD.

    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 0000775133

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR