BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIEVE THERMODILITATION SYSTEM

    MDR report key: 1820878 · Received August 31, 2010

    Report

    Report Number
    3005099803-2010-03617
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 9, 2010
    Manufacturer
    ACCELLENT ENDOSCOPY JUAREZ
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)-FISTULA ADDED PER ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). TEMPERATURE PROBE. DEVICE DISPLAYS ERROR MESSAGE; ADDED PER ADDITIONAL INFORMATION.

    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, THE PROCEDURE WAS COMPLETED WITH NO APPARENT ISSUES. THREE DAYS POST-PROCEDURE, THE BSC TERRITORY MANAGER (TM) WAS MADE AWARE THAT THE PATIENT HAD A THERMAL INJURY ON HIS SCROTUM AND THE UNDERSIDE OF THE PENIS. THE PHYSICIAN TREATED THE INJURY WITH SILVADENE TOPICAL CREAM AND PERCOCET. THE PATIENT IS RECOVERING. FOLLOW UP WITH THE TM REVEALED THAT THE PATIENT WAS UNDER GENERAL ANESTHESIA. A PROLIEVE TUMT WAS DONE FIRST. THE TM CONFIRMED THERE WERE NO BALLOON LEAKS DURING THE PROLIEVE TREATMENT. THREE OR FOUR ULTRASOUND PHOTOS WERE TAKEN DURING THE CASE, AND NO CATHETER MIGRATION WAS WITNESSED. ONCE COMPLETED, A LASER-HOLAP FIBER WAS USED TO MAKE AN INCISION IN THE BLADDER NECK. THE LASER WAS BEING USED IN PLACE OF THE RADIOFREQUENCY (RF) ELECTRODE, BUT THE LASER DID NOT WORK IN THE MANNER THE PHYSICIAN HOPED IT WOULD. ADJUSTMENTS TO THE LASER POWER WERE MADE A NUMBER OF TIMES, THEN THE PHYSICIAN DECIDED TO USE A CUTTING LOOP OR ELECTRONIC CUTTING BLADE TO MAKE THE INCISION IN THE BLADDER NECK. AFTER THE INCISION WAS MADE, THE CASE WAS COMPLETE. REPORTEDLY, THE PATIENT SUSTAINED A 2ND DEGREE BURN WHICH COVERED 4 INCHES IN LENGTH AND 1.5-2 INCHES IN WIDTH OF THE SCROTUM AND UNDERNEATH OF PENIS. THE PHYSICIAN REPORTED ON (B)(6) 2010, THAT THE PATIENT WAS NOT IN PAIN POST PROCEDURE. THE PATIENT WAS PRESCRIBED PAIN KILLERS AND A SILVADENE TO HELP HEAL THE BURNED AREA AND IS HEALING WELL. A CATHETER WAS INSERTED IMMEDIATELY AFTER THE PROCEDURE AND WILL BE KEPT IN UNTIL THE BURN IS HEALED. ORIGINALLY, THE CATHETER WAS TO BE TAKEN OUT AFTER 3-4 DAYS. AFTER THE BURN WAS DISCOVERED, THE PHYSICIAN DECIDED TO LEAVE THE CATHETER IN. THE PHYSICIAN SAID THAT HE WAS GOING TO CHECK ON THIS PATIENT THROUGHOUT THE WEEK POST THE SURGERY TO TRACK HIS RECOVERY. THE PATIENT WAS ON THE ANTIBIOTIC CIPRO AND RECENTLY CHANGED TO DURICES. THE PATIENT IS USING HYPERBOLIC CHAMBER THERAPY TO ASSIST WITH THE HEALING OF THE BURN. PATIENT HAS HAD NO OBSTRUCTION WITH BOWEL MOVEMENTS AND HIS BODILY FUNCTIONS ARE NORMAL.

    Description of Event or Problem · 1

    ON (B)(6) 2010, FOLLOW UP WITH BSC TECHNICIAN REVEALED AFTER THE PROLIEVE PROCEDURE WAS COMPLETED, THE PHYSICIAN CONTINUED TO PERFORM THE ADDITIONAL PROCEDURES AS NOTED IN THE INITIAL MEDWATCH REPORT, TO MAKE AN INCISION IN THE BLADDER NECK. THE TECHNICIAN ALSO STATED THAT THE RECTAL TEMPERATURE MONITOR (RTM) WAS IN PLACE AND FUNCTIONED PROPERLY. THE RTM TEMPERATURE REACHED 38-39 DEGREES CELSIUS. THE TECHNICIAN ENSURED THAT THE RTM WAS MAKING CONTACT WITH THE TISSUE BY HOLDING THE RTM INTO THE RECTUM DURING THE ENTIRE PROCEDURE. FOLLOW UP WITH THE COMPLAINANT REVEALED THE PATIENT HAS A URETHRAL COETANEOUS FISTULA AT THE PENILE SCROTAL JUNCTION. THE PHYSICIAN WAS HOLDING THE CATHETER IN PLACE DURING THE ENTIRE PROLIEVE PROCEDURE. PROLIEVE CONSOLE TEMPERATURE VS. TIME CURVE DATA, RAW PROCEDURE DATA AND ULTRASOUND PHOTOS DURING THE PROLIEVE TREATMENT WERE REQUESTED BY BSC FOR EVALUATION. FOLLOW UP WITH THE OFFICE OF RISK MANAGEMENT AT THE HOSPITAL ON SEPTEMBER 10, 2010 REVEALED THE PATIENT IS IMPROVING AND THE CATHETER IS STILL IN PLACE.

    Description of Event or Problem · 1

    ON (B)(6), 2010, FOLLOW UP WITH A BSC TERRITORY MANAGER (TM), REVEALED THAT THE BURN WAS HEALING WELL, THE PATIENT'S URETHRA WAS INTACT, THE PHYSICIAN PERFORMED A CYSTOSCOPY PROCEDURE AND REPORTED THE EPITHELIUM LOOKED GOOD, THE CATHETER HAD BEEN REMOVED AFTER BEING IN FOR 6 WEEKS AND THE PATIENT WAS NOW VOIDING URINE ON HIS OWN.

    Description of Event or Problem · 1

    ON (B)(6) 2010, FOLLOW UP WITH BSC TECHNICIAN REVEALED THAT DURING THE PROCEDURE THERE WAS A RECTAL TEMPERATURE MONITOR (RTM) LOW TEMPERATURE ERROR MESSAGE AND THE RTM WAS REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILITATION SYSTEM SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY MEQ ACCELLENT ENDOSCOPY JUAREZ M0068808260 0000729105

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention