BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE SPANNER TEMPORARY PROSTATIC STENT

    MDR report key: 1056485 · Received May 30, 2008

    Report

    Report Number
    3005249627-2008-00008
    Event Type
    Malfunction
    Date Received
    May 30, 2008
    Date of Event
    March 13, 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. A REVIEW OF DEVICE HISTORY RECORDS (DHR) FOR THE RELEVANT SPANNER LOT REVEALED NO INDICATION THAT THE DEVICE USED DID NOT MEET SPECIFICATIONS. PHYSICIAN FEEDBACK INDICATES THE PATIENT WAS ABLE TO URINATE AT THE TIME OF DEVICE REMOVAL. WHEN ATTEMPTING DEVICE REMOVAL, THE PHYSICIAN COULDN'T FIND THE RETRIEVAL SUTURE AND DISCOVERED THE DEVICE MIGRATED INTO THE BLADDER. A CYSTOSCOPY WAS PERFORMED. THIS FORM FDA 3500A IS BEING SUBMITTED AFTER THE REQUIRED 30-DAY TIME FRAME IN RESPONSE TO RECENT INTERACTIONS BETWEEN ABBEYMOOR, THE OFFICE, AND THE FDA REPORTING SYSTEMS MONITORING BRANCH IN WHICH MIGRATION EVENTS WITH CYSTOSCOPIC REMOVAL WERE DEEMED MDR REPORTABLE. (ABBEYMOOR INITIALLY DETERMINED THAT AN 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 IN 2008, AND REMOVED BY CYSTOSCOPY ON APPROXIMATELY 2008. THE PHYSICIAN STATED THE REMOVAL WAS SIMPLE AND THE DEVICE CAME OUT WELL. INDICATION FOR USE IS POST ACUTE URINARY RETENTION.

    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 159

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention