BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE SPANNER TEMPORARY PROSTATIC STENT

    MDR report key: 1056494 · Received May 30, 2008

    Report

    Report Number
    3005249627-2008-00006
    Event Type
    Malfunction
    Date Received
    May 30, 2008
    Date of Event
    February 27, 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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DEVICE WAS RETURNED FOR EVALUATION. THE DISTAL ANCHOR/RETRIEVAL TETHER/BALLOON PLUG ASSEMBLY WERE NOT RETURNED. A MICROSCOPIC EVALUATION OF THE RETURNED DEVICE SHOWED DEBRIS IN THE BALLOON DEFLATION PORT. FURTHER ANALYSIS SUGGESTS THE DEBRIS IS LIKELY THE PROXIMAL TIP (EPOXY DOME) OF THE BALLOON PLUG ASSEMBLY. (THE BALLOON PLUG ASSEMBLY IS LOCATED AT THE END OF THE RETRIEVAL TETHER AND IS INSERTED IN THE BALLOON DEFLATION PORT). FUNCTIONAL TESTING SHOWED THE BALLOON INFLATED NORMALLY AND BALLOON DRAIN (DEFLATION) MET SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW FOR THE LOT WAS PERFORMED; NO CONCERNS WERE RAISED REGARDING THE BALLOON PLUG ASSEMBLY. LIKELY ROOT CAUSE OF THE EVENT APPEARS TO BE THE PRESENCE OF DEBRIS (LIKELY FROM THE EPOXY DOME ON THE BALLOON PLUG ASSEMBLY) IN THE BALLOON DEFLATION PORT, WHICH REDUCED DRAINAGE FLOW RATE AND DELAYED COMPLETE BALLOON DEFLATION. BASED ON THE CYSTOSCOPIC PROCEDURE, THE PHYSICIAN SURMISED THE BALLOON DID NOT FULLY DEFLATE AT TIME OF INITIAL REMOVAL AND THAT FULL DEFLATION OCCURRED WHILE THE DEVICE WAS RESIDING IN THE BLADDER. PHYSICIAN STATED THAT DURING THE CYSTOSCOPY, HE COULD SEE THE BALLOON WAS DEFLATED AND GRASPED THE DEVICE SUTURE PULLING THE DEVICE OUT WITHOUT ANY PROBLEM. 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 AN MDR WAS NOT REQUIRED FOR THIS EVENT BASED ON RESULTS OF A CLINICIAN-BASED RISK ASSESSMENT).

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED HE HAD A DIFFICULT TIME REMOVING THE SPANNER USING THE RETRIEVAL TETHER. DURING THE REMOVAL PROCEDURE, THE DEVICE WAS PARTIALLY REMOVED TO THE POINT WHERE THE DEVICE ANCHOR PROTRUDED FROM THE PATIENT'S MEATUS. THE PHYSICIAN CUT THE DISTAL ANCHOR OFF AND PUSHED THE STENT INTO THE PATIENT'S BLADDER FOR LATER REMOVAL DURING A PLANNED CYSTOSCOPIC PROCEDURE. THE SPANNER WAS INITIALLY POSITIONED IN 2007, AND REMOVED BY CYSTOSCOPY IN 2008. INDICATION FOR USE IN THIS PATIENT IS UNKNOWN.

    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 151

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention