BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIEVE THERMODILATATION KIT

    MDR report key: 1051088 · Received May 22, 2008

    Report

    Report Number
    3005099803-2008-00523
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; AS IT WAS DISPOSED OF BY THE USER FACILITY; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    ON APRIL 22, 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MALE PATIENT (WEIGHT UNKNOWN) UNDERWENT TREATMENT WITH A PROLIEVE THERMODILATATION KIT ON ELEVEN DAYS EARLIER, FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH). ACCORDING TO THE COMPLAINANT, DURING REMOVAL OF THE PROLIEVE CATHETER, THE PHYSICIAN NOTICED BLOOD COMING FROM THE URETHRA. THE PATIENT WAS CATHETERIZED BUT THE BLEEDING WOULD NOT STOP. THE PATIENT WAS ADMITTED TO THE HOSPITAL. A RIGID SCOPE WAS PLACED AND BLOOD CLOTS WERE NOTED IN THE BLADDER AND THE URETHRA APPEARED TO BE "SCRAPED UP." THE BLADDER WAS IRRIGATED AND THE CLOTS WERE EXTRACTED. THE PATIENT WAS SENT HOME WITH A CATHETER. THE PATIENT HAS BEEN TO THE HOSPITAL SEVERAL TIMES SINCE THE PROCEDURE DATE DUE TO BLEEDING AND HAS HAD BLOOD CLOTS IRRIGATED FROM HIS BLADDER NUMEROUS TIMES. THE PATIENT ALSO SUFFERED A SEVERE NOSEBLEED AND HAS HAD BLEEDING FROM AN IV PUNCTURE SITE. A PLATELET TEST WAS ADMINISTERED AND REVEALED A LOW PLATELET COUNT. THE PHYSICIAN STATED THAT THE PATIENT MAY HAVE A COAGULATIVE DISORDER. THE PHYSICIAN PERFORMED FULGURATION OF THE PROSTATIC URETHRA TO STOP THE BLEEDING WHICH PERSISTED AFTER THE PROLIEVE TREATMENT. A FOLEY CATHETER WAS PLACED FOR A WEEK (ESTIMATED). AS THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER, BLEEDING OCCURRED AND HE PERFORMED A SECOND FULGURATION. SIGNIFICANT BLOOD CLOTS HAD FORMED IN THE BLADDER WHICH COULD NOT BE REMOVED TRANSURETHRALLY. A SUPRAPUBIC INCISION WAS MADE AND THE CLOTS WERE MANUALLY REMOVED FROM THE PATIENT. IT IS THE PHYSICIAN'S OPINION THAT THE INSERTION OF THE PROLIEVE CATHETER CAUSED SOME DAMAGE TO THE PROSTATIC URETHRA WHICH BECAME APPARENT AFTER THE TREATMENT. THE PATIENT DID NOT BLEED DURING THE TREATMENT ITSELF, HOWEVER, WHEN THE PROLIEVE CATHETER WAS REMOVED, THERE WAS SIGNIFICANT BLOOD COMING FROM THE URETHRA. HIS VISUAL INSPECTION DURING SUBSEQUENT FULGURATION TREATMENTS REVEALED THAT THE URETHRA WAS "TORN UP" FROM THE CATHETER. THIS APPARENTLY LEAD TO THE BLEEDING THAT CONTINUED FOR SEVERAL WEEKS. THE CONTINUED CATHETERIZATION AND THE REMOVAL AND INSERTION OF THE FOLEY CATHETER HAD CAUSED CONTINUED TRAUMA AND HAS NOT ALLOWED THE AREA TO HEAL WELL. AS OF THE FOLLOWING MONTH, THE PATIENT'S URINE HAS BEEN CLEAR AND IS EXPECTED TO BE RELEASED FROM THE HOSPITAL SOON. THE PHYSICIAN'S CONCERN IS THAT THE NECESSARY FULGURATION THAT OCCURRED TO STOP BLEEDING HAS POTENTIALLY CAUSED DAMAGE TO THE PROSTATE AREA INCLUDING HIS EXTERNAL SPHINCTER. ALSO, IT IS ANTICIPATED THAT SOME STRICTURES MAY OCCUR. THE PATIENT HAS HAD COAGULATIVE DISORDERS IN THE PAST. DURING THE LAST TWO SURGICAL PROCEDURES (NON-UROLOGICAL), THERE WAS DIFFICULTY IN STOPPING BLEEDING AND EXTREME BRUISING OCCURRED. NUMEROUS BLOOD TESTS WERE CONDUCTED AND ACCORDING TO THE PHYSICIAN, NOTHING TOO UNUSUAL WAS FOUND. THE PATIENT WAS NOT TAKING BLOOD THINNER OR ASPIRIN DURING THE PROLIEVE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILATATION KIT MEQ BOSTON SCIENTIFIC CORPORATION M0068808022 0000604568

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R