BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION SYSTEM

    MDR report key: 2220683 · Received August 23, 2011

    Report

    Report Number
    3005099803-2011-02757
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF PORT CUT IN MATERIAL. NO EVIDENCE OF BALLOON PUNCTURE FROM A GUIDEWIRE. NO INDICATION OF IMPERFECTIONS OR OBSTRUCTIONS PRESENT ON THE ANCHORING BALLOON PORTION OF THE CATHETER THAT COULD HAVE CAUSED THE ANCHORING BALLOON TO NOT DEFLATE. THE PROLIEVE CATHETER WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS WITHOUT THE CUT ANCHORING BALLOON PORT. DURING THE INITIAL VISUAL EXAM, THERE WAS NO EXCESSIVE GLUE OBSERVED, THE BONDS WERE INTACT AND THERE WAS NO EVIDENCE OF PUNCTURE FROM A GUIDEWIRE. THE COMPRESSION BALLOON FILLED APPROPRIATELY WITHOUT LEAKS OBSERVED AND THE PRESSURE WAS MAINTAINED. FUNCTIONAL ANALYSIS ON THE ANCHORING BALLOON COULD NOT BE PERFORMED BECAUSE THE CHANNEL PORT TO THE ANCHORING BALLOON WAS REMOVED. FURTHER ENGINEERING ANALYSIS WAS PERFORMED AND THE EXTERIOR PART OF THE ANCHORING BALLOON WAS REMOVED FROM THE CATHETER SHAFT. THERE WAS STILL NO EVIDENCE OF PUNCTURES BY A GUIDEWIRE. THERE WAS NO INDICATION OF IMPERFECTIONS OR OBSTRUCTIONS PRESENT ON THE ANCHORING BALLOON PORTION OF THE CATHETER THAT COULD HAVE CAUSED THE ANCHORING BALLOON TO NOT DEFLATE AT THE END OF THE PROCEDURE. THE ROOT CAUSE CLASSIFICATION ASSIGNED TO THIS COMPLAINT IS UNDETERMINABLE AS THE ANALYSIS DID NOT CONFIRM ANY DEFECTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    FOLLOW UP WITH THE BOSTON SCIENTIFIC CORPORATION (BSC) SALES REPRESENTATIVE REVEALED THAT PER THE ROCKY MOUNTAIN MOBILE SERVICE TECHNICIAN THAT WAS PRESENT AT THE CASE, THEY USED A GUIDEWIRE TO POKE A HOLE IN THE ANCHORING BALLOON SO THE WATER WOULD LEAK OUT. THEY DECIDED TO CUT THE ANCHORING BALLOON PORT, AS A BACK UP, TO RELEASE THE WATER IN THE ANCHORING BALLOON, BEFORE REMOVING CATHETER FROM THE PATIENT. NO WATER COME OUT FROM THE CUT PORT AREA. THE BALLOON WAS COMPLETELY DEFLATED WHEN IT WAS REMOVED.

    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, WHEN IT WAS TIME TO REMOVE THE CATHETER, WHEN TREATMENT WAS COMPLETED, THE ANCHOR BALLOON WOULD NOT DEFLATE. THE PHYSICIAN COULD NOT DEFLATE ANCHOR BALLOON THOUGH HE MADE SEVERAL ATTEMPTS. FINALLY, A GUIDEWIRE WAS USED TO PUNCTURE THE ANCHOR BALLOON AND REMOVE THE CATHETER. THERE WERE NO COMPLICATIONS. THE PATIENT'S CONDITION WAS REPORTED AS OKAY.

    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 0000833892

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR