BEUDAMED
    FDA Adverse Event Other Summary report: N

    THE SPANNER TEMPORARY PROSTATIC STENT

    MDR report key: 1813662 · Received August 6, 2010

    Report

    Report Number
    3005249627-2010-00004
    Event Type
    Other
    Date Received
    August 6, 2010
    Date of Event
    July 9, 2010
    Report Date
    August 11, 2010
    Manufacturer
    ABBEYMOOR MEDICAL INC.
    Product Code
    MER
    PMA / PMN Number
    P060010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: (B)(6) MEDICAL REQUESTED THE DEVICE BE RETURNED FOR EVAL. THE DEVICE WAS SUBJECTED TO A VISUAL EXAMINATION AND FUNCTIONAL TESTING. RETURNED DEVICE ANALYSIS SHOWED THE SURVEYOR DEVICE APPEARED TO FUNCTION NORMALLY WITH THE EXCEPTION OF THE WIRE MOVEMENT. THIS WAS CAUSED BY A SEVERE BEND IN THE PROBE WIRE. THE CAUSE OF THE BEND IN THE WIRE IS UNK BUT WAS MOST LIKELY DUE TO MANIPULATIONS REQUIRED DURING THE SURVEYOR REMOVAL. THE COMPONENTS MEASURED MET SPECIFICATION. THE DEVICE PROFILE MET CURRENT DESIGN SPECIFICATIONS. THE BALLOON INFLATION AND DEFLATION TIME MET SPECIFICATIONS. DHR REVIEW WAS NOT DONE BASED ON THE COMPLAINT, ALSO LOT NUMBER OF DEVICE IS UNK. THE SALES REP THAT OBSERVED THE SPANNER MEASUREMENT PROCESS STATED THE DEVICE APPEARED TO FUNCTION NORMALLY UNTIL REMOVAL WAS ATTEMPTED.

    Description of Event or Problem · 1

    A SALES REP CALLED TO SEEK ADVICE ABOUT A SURVEYOR THAT WAS STUCK IN A PATIENT AFTER THE PHYSICIAN ATTEMPTED TO TAKE A MEASUREMENT FOR THE INSERTION OF A SPANNER. THE PHYSICIAN CONFIRMED THE BALLOON WAS DEFLATED PRIOR TO THE REMOVAL ATTEMPT VIA ULTRASOUND. THE PHYSICIAN THEN VIEWED THE URETHRA WITH A CYSTOSCOPE AND CONCLUDED THE SURVEYOR HAD GONE DOWN A FALSE PASSAGE. WITH THE AID OF THE CYSTOSCOPE, THE PHYSICIAN WAS ABLE TO REMOVE THE SURVEYOR. THE PHYSICIAN ATTEMPTED THE MEASUREMENT WITH A DIFFERENT SURVEYOR, WAS SUCCESSFUL AND A SPANNER WAS PLACED. THE SALES REP CALLED AFTER THE PROCEDURE TO STATE THE PT APPEARED TO BE DOING WELL. THE SALES REP SPOKE TO THE PHYSICIAN ON (B)(4), FIVE DAYS AFTER SPANNER PLACEMENT. THE PHYSICIAN REPORTED THE PATIENT VOIDED GREAT FOR TWO DAYS THEN HAD TO GO TO THE ER BECAUSE HE WENT INTO RETENTION. PHYSICIAN FEELS A CLOT HAD CLOGGED THE STENT. NO FURTHER F/U INFO REGARDING THE PT HAS BEEN RECEIVED. INDICATION FOR USE WAS POST TRANSURETHRAL INCISION OF THE PROSTATE (TUIP); TIME FRAME SINCE TUIP IS UNK. PT PRESENTED WITH A CATHETER PRIOR TO SPANNER MEASUREMENT AND INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE SPANNER TEMPORARY PROSTATIC STENT TEMPORARY PROSTATIC STENT MER ABBEYMOOR MEDICAL INC. SURV-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention