BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE SPANNER TEMPORARY PROSTATIC STENT

    MDR report key: 1041247 · Received May 9, 2008

    Report

    Report Number
    3005249627-2008-00003
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    July 21, 2007
    Report Date
    May 7, 2008
    Manufacturer
    ABBEYMOOR MEDICAL INC.
    Product Code
    NZC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. A REVIEW OF DEVICE HISTORY RECORDS (DHR) FOR THIS SPANNER LOT REVEALED NO INDICATION THAT THE DEVICE USED DID NOT MEET SPECIFICATIONS. DEVICE NOT RETURNED - NO EVAL WILL BE PERFORMED. THIS EVENT OCCURRED OUTSIDE OF THE UNITED STATES.

    Description of Event or Problem · 1

    WHILE SOLICITING PRODUCT PERFORMANCE FEEDBACK FROM CLINICIANS, THE DEVICE MANUFACTURER LEARNED OF A DEVICE MIGRATION EVENT. THE PT VOIDED FINE AFTER SPANNER INSERTION IN 2007. ON THREE DAYS LATER, HE WAS UNABLE TO VOID (ACUTE URINARY RETENTION). THE REMOVAL TETHER WAS NOT VISIBLE AND A FOLEY CATHETER WAS INSERTED, WHICH PUSHED THE SPANNER INTO THE BLADDER. THE DEVICE WAS REMOVED VIA CYSTOSCOPY. ACCORDING TO THE CLINICIAN, ACUTE URINARY RETENTION MAY HAVE BEEN CAUSED DUE TO OBSTRUCTED DEBRIS, TRUE CAUSE IS UNKNOWN. INDICATION FOR USE: PT WAS ON WAITING LIST FOR OPEN PROSTATECTOMY SURGERY. THE SPANNER HAD BEEN IN USE FOR THREE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE SPANNER TEMPORARY PROSTATIC STENT TEMPORARY PROSTATIC STENT NZC ABBEYMOOR MEDICAL INC. CE SPNR-9C 97

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention