BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIEVE THERMODILITATION KIT

    MDR report key: 1071616 · Received July 9, 2008

    Report

    Report Number
    3005099803-2008-01103
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO EVENTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MANUFACTURER REPORT 3005099803-2008-01102 FOR A DESCRIPTION OF THE SECOND EVENT. IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MALE PATIENT UNDERWENT TREATMENT WITH A PROLIEVE THERMODILITATION KIT AS PART OF THE POST-MARKET STUDY USING PROLIEVE FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH). REPORTEDLY, WHEN TRYING TO PLACE THE FIRST PROLIEVE CATHETER, THE PHYSICIAN HAD DIFFICULTY NAVIGATING THE S BEND. DURING THIS FIRST ATTEMPT, THE DEVICE BECAME SO BLOODIED THE PHYSICIAN WAS UNABLE TO USE IT. AS THE PHYSICIAN WAS TRYING TO PLACE THE SECOND PROLIEVE CATHETER, A FALSE CHANNEL DEVELOPED AND THE PHYSICIAN ABORTED THE CASE. NEXT, THE PHYSICIAN TRIED TO PLACE A FOLEY CATHETER (UNKNOWN MANUFACTURER) BUT BECAUSE THE PATIENT WAS BLEEDING SO MUCH; HE WAS UNABLE TO PLACE THE DEVICE. THE PATIENT WAS TAKEN TO THE AMBULATORY SURGERY CENTER AND TREATED. THE PATIENT WAS SCOPED AND HAD A COUNCIL TIP CATHETER PLACED (UNKNOWN MANUFACTURER). ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED ADDITIONAL SYMPTOMS: HYPERTENSION, BLEEDING FROM THE BULBAR URETHRA, BLADDER SPASMS. THE PATIENT WAS TREATED FOR THESE SYMPTOMS AND THE FALSE CHANNEL WITH THE FOLLOWING CONCOMITANT MEDICATIONS: LABETALOL, LEVAQUIN, DIAZEPAM, TYLENOL, GENTAMICIN, LIDOCAINE, AND KETOROLAC. HYPERTENSION, COMMENCED ON THREE DAYS PRIOR TO ORIGINAL DATE, AND WAS RESOLVED ON THE SAME DAY. PUNCTURED HOLE IN URETHRA (FALSE CHANNEL), COMMENCED ON THE SAME DAY, AND WAS RESOLVED ON THIRTEEN DAYS LATER. BLEEDING FROM BULBAR URETHRA, COMMENCED ON THREE DAYS PRIOR TO ORIGINAL DATE, AND WAS RESOLVED ON THREE DAYS LATER. BLADDER SPASMS, COMMENCED ON THREE DAYS PRIOR TO ORIGINAL DATE, AND WAS RESOLVED ON THREE DAYS LATER. SUBSEQUENTLY, THE COUNCIL TIP CATHETER WAS REMOVED ON THE SAME DAY, AND THE PATIENT'S CONDITION WAS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILITATION KIT MEQ BOSTON SCIENTIFIC CORPORATION M0068808022 0000605787

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other