BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE SPANNER TEMPORARY PROSTATIC STENT

    MDR report key: 1565036 · Received December 18, 2009

    Report

    Report Number
    3005249627-2009-00004
    Event Type
    Injury
    Date Received
    December 18, 2009
    Date of Event
    November 23, 2009
    Report Date
    December 18, 2009
    Manufacturer
    ABBEYMOOR MEDICAL INC.
    Product Code
    NZC
    PMA / PMN Number
    P060010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO ABBEYMOOR MEDICAL FOR EVALUATION. THE SPANNER WAS RECEIVED WITHOUT THE DISTAL ANCHOR OR THE RETRIEVAL SUTURE; THEREFORE, THE LOCATION OF THE FAILURE COULD NOT BE DETERMINED. THE SPANNER WAS HEAVILY ENCRUSTED, ESPECIALLY IN THE PROXIMAL BALLOON REGION. THE STENT LUMEN WAS OCCLUDED WITH DEBRIS IN TWO LOCATIONS. INVESTIGATION RESULTS SUGGEST, THE LIKELY REASON FOR THE DEVICE RETRIEVAL SUTURE BREAKING AT THE TIME OF REMOVAL IS ATTRIBUTED TO THE HEAVY ENCRUSTATION ON THE SPANNER PROXIMAL END WHICH PREVENTED THE SPANNER FROM BEING WITHDRAWN FROM THE URETHRA IN THE NORMAL FASHION. DHR REVIEW WAS NOT CONDUCTED BASED ON RESULTS OF THE DEVICE INSPECTION. DEVICE MET SPECIFICATIONS.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED WHEN HE WENT TO REMOVE THE SPANNER STENT, IT WAS VERY TIGHT, THE RETRIEVAL STRING BROKE WHEN HE PULLED ON IT, AND THE STENT WAS THEN STUCK IN THE PATIENT. PHYSICIAN REMOVED THE SPANNER STENT VIA CYSTOSCOPY IN A SURGICAL SUITE LATER THAT SAME EVENING. HE PUSHED THE STENT INTO THE PATIENT'S BLADDER THEN USED A FORCEPS TO EXTRACT THE STENT. PHYSICIAN STATED THE STENT WAS REALLY ENCRUSTED AND THAT HE THOUGHT THE ENCRUSTATION ON THE BALLOON WAS THE PROBLEM. THE PATIENT HAS HAD SOME EPISODES OF UTI & BLEEDING BUT DECLINED AN EARLY CHANGE IN THE STENT. THIS WAS THE SECOND SPANNER WORN BY THE PATIENT AND HAD BEEN IN PLACE FOR 10 WEEKS. THE INITIAL SPANNER STENT WAS INSERTED AFTER DIRECT VISUAL INTERNAL URETHROTOMY (DVIU) FOR STRICTURE REPAIR POST SALVAGE CRYOTHERAPY. PATIENT HAD DISCOMFORT IN THE OFFICE WHEN THEY TRIED TO REMOVE THE STENT AND ALSO WENT INTO RETENTION, AS THE STENT PLUGGED UP WITH DEBRIS WHILE WAITING TO GET HIM INTO SURGERY. PATIENT HAD SOME MILD BLEEDING; A FOLEY CATHETER WAS PLACED FOR OVERNIGHT. THE NEXT DAY, THE FOLEY WAS REMOVED, AND ANOTHER SPANNER WAS PLACED. ADDITIONAL CORRESPONDENCE FROM PHYSICIAN STATES, PATIENT IS DOING WELL.

    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-7HA 217

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention