BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE SPANNER TEMPORARY PROSTATIC STENT

    MDR report key: 1041249 · Received May 9, 2008

    Report

    Report Number
    3005249627-2008-00001
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    December 1, 2006
    Report Date
    May 7, 2008
    Manufacturer
    ABBEYMOOR MEDICAL INC.
    Product Code
    NZC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF DEVICE HISTORY RECORDS (DHR) FOR RELEVANT SPANNER LOTS REVEALED NO INDICATION THAT THE DEVICE USED DID NOT MEET SPECIFICATIONS. THIS FORM FDA IS BEING SUBMITTED AFTER THE REQUIRED 30-DAY TIME FRAME IN RESPONSE TO RECENT INTERACTIONS BETWEEN ABBEYMOOR, THE FDA LOCAL DISTRICT OFFICE, AND THE FDA REPORTING SYSTEMS MONITORING BRANCH IN WHICH MIGRATION EVENTS WITH CYSTOSCOPIC REMOVAL WERE DEEMED MDR REPORTABLE. (ABBEYMOOR INITIALLY DETERMINED THAT A MDR WAS NOT REQUIRED FOR THIS EVENT BASED ON RESULTS OF A CLINICIAN-BASED RISK ASSESSMENT.) EXPLANATION OF EVALUATION CODES USED.

    Description of Event or Problem · 1

    WHILE SOLICITING PRODUCT PERFORMANCE FEEDBACK FROM CLINICIANS, THE DEVICE MFR LEARNED OF A DEVICE MIGRATION EVENT FOLLOWED BY ACUTE URINARY RETENTION (AUR). DEVICE MIGRATION INTO THE BLADDER WAS CONFIRMED BY X-RAY. A FOLEY CATHETER WAS INSERTED TO RESTORE BLADDER DRAINAGE. CYSTOSCOPIC REMOVAL OF THE DEVICE WAS PERFORMED. NO PT INJURY WAS REPORTED. NO PT INFO OR DEVICE LOT NUMBER WAS PROVIDED. INDICATION FOR USE IS UNK. NUMBER OF DAYS THE SPANNER HAD BEEN IN USE IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE SPANNER TEMPORARY PROSTATIC STENT TEMPORARY PROSTATIC STENT NZC ABBEYMOOR MEDICAL INC. SPNR-6C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention