BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE SPANNER TEMPORARY PROSTATIC STENT

    MDR report key: 1056482 · Received May 30, 2008

    Report

    Report Number
    3005249627-2008-00007
    Event Type
    Malfunction
    Date Received
    May 30, 2008
    Date of Event
    March 25, 2008
    Report Date
    May 29, 2008
    Manufacturer
    ABBEYMOOR MEDICAL INC.
    Product Code
    NZC
    PMA / PMN Number
    P060010
    Adverse Event
    Yes
    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. 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

    WHILE SOLICITING PRODUCT PERFORMANCE FEEDBACK FROM THE PATIENT, THE DEVICE MANUFACTURER LEARNED OF A DEVICE MIGRATION EVENT. THE PATIENT STATED THAT HE WENT TO THE EMERGENCY ROOM IN 2008 UNABLE TO URINATE. THE ER PHYSICIAN INSERTED A CATHETER WITHOUT REMOVING THE SPANNER, THEREBY PUSHING THE DEVICE INTO THE PATIENT'S BLADDER. THE DEVICE WAS INITIALLY POSITIONED ON THE PREVIOUS MONTH AND REMOVED VIA CYSTOSCOPY ON TWENTY TWO DAYS AFTER THE ORIGINAL DATE. NO PATIENT INJURY WAS REPORTED. INDICATION FOR USE IS POST E-BEAM TREATMENT FOR PROSTATE CANCER.

    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- 161

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention