BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE SPANNER TEMPORARY PROSTATIC STENT

    MDR report key: 1056491 · Received May 30, 2008

    Report

    Report Number
    3005249627-2008-00004
    Event Type
    Malfunction
    Date Received
    May 30, 2008
    Date of Event
    January 23, 2008
    Report Date
    May 29, 2008
    Manufacturer
    ABBEYMOOR MEDICAL, INC.
    Product Code
    NZC
    PMA / PMN Number
    P060010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. PHYSICIAN FEEDBACK SUGGESTS THE PATIENT, WHO RESIDED IN A NURSING HOME, WAS DOING OKAY WHILE WEARING THE SPANNER. THE PHYSICIAN SUSPECTS THAT NURSING HOME PERSONNEL MAY HAVE ATTEMPTED INSERTION OF A CATHETER INTO THE PATIENT, THEREBY PUSHING THE SPANNER UP INTO THE BLADDER. THIS FORM FDA 3500A 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 THE MDR WAS NOT REQUIRED FOR THIS EVENT BASED ON RESULTS OF A CLINICIAN-BASED RISK ASSESSMENT).

    Description of Event or Problem · 1

    DURING ABBEYMOOR MEDICAL REVIEW OF A PHYSICIAN PROVIDED CYSTOSCOPY VIDEO, THE DEVICE MANUFACTURER OBSERVED A COMPLETE DEVICE MIGRATION. THE DEVICE WAS INITIALLY POSITIONED ON 12/19/2007 AND REMOVED BY CYSTOSCOPY IN EARLY 2008. NO KNOWN PATIENT INJURY OR HOSPITALIZATION. NO DEVICE LOT NUMBER PROVIDED. INDICATION FOR USE IS DIFFERENTIAL DIAGNOSIS. NUMBER OF DAYS THE SPANNER HAD BEEN IN USE IS 35 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. SPNR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention